Transfusion Medicine Reviews
Volume 26, Issue 1 , Pages 14-26, January 2012

Improving Safety for Young Blood Donors

  • Anne F. Eder

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Anne F. Eder, MD, PhD, American Red Cross, Biomedical Services, National Headquarters, Washington, DC, USA.

published online 29 August 2011.

Article Outline

Young blood donors between the ages of 16 and 18 years contribute substantially to the blood supply in the United States, accounting for about 14% of the allogeneic whole blood collected by the American Red Cross in 2010. However, studies have consistently demonstrated that the donors' age, total blood volume, and first-time donation status independently contribute to the risk of syncopal reactions after whole blood donation. Efforts to improve the donation experience are crucial not only to ensure the health and well-being of blood donors but also to sustain an adequate blood supply. Even minor reactions or temporary deferrals discourage individuals from donating blood again. Shifting population demographics and advances in medical care in the United States and other countries predict that the need for blood will increase, whereas blood donation by the older generations declines each year. Broad deferral strategies and precautionary measures have further winnowed the eligible donor pool, but their contribution to transfusion safety remains controversial. Consequently, blood centers that depend on recruiting and retaining adolescent blood donors have made concerted efforts to improve safety, especially on high school blood drives. Population-based operational tactics to improve donation safety focus on donor education, the drive environment, or recruiting individuals who are less likely to have reactions. Physiologic strategies modulate the donors' response to blood loss, decreasing their susceptibility to a donation-related reaction. This review examines the published data supporting the measures recently taken by blood centers to reduce the risk of syncopal reactions among young, whole blood donors.

 

BLOOD DONATION BY teenagers has steadily increased each year in the United States, as more states have lowered the minimum donation age to 16 years [1], [2], [3], [4]. Ten years ago, AABB Standards required volunteer blood donors to be at least 17 years old but allowed exceptions if permitted by state laws. In 2005, about 15 states allowed blood donation by 16-year-olds with parental permission; by 2010, this number had reached 34, with several more states deliberating on the issue [1]. As blood donation by older individuals decreases and as more stringent precautionary measures are taken that result in the disqualification of large segments of the general population, many blood centers increasingly depend on high-school- and college-aged donors to meet the demand in a community [5], [6], [7], [8]. The American Red Cross (ARC) observed a 50% increase in 16- to 19-year-old donors between 1996 and 2005 [5]. By 2010, annual blood donations by 16- to 18-year-olds exceeded 800 000 or about 14% of the whole blood collected by ARC, primarily on high school drives during the school year (September through May) [1]. In contrast, most blood centers in Europe, Canada, Japan, and other countries require blood donors to be at least 17 years old and differ with respect to other criteria used to select allogeneic blood donors compared with US blood centers [9], [10], [11].

Regardless, both US and international blood centers have consistently shown that reactions are inversely correlated with donor age, and young donors are more susceptible to syncope and related reactions after whole blood collection than older donors [1], [2], [3], [4], [12], [13], [14], [15]. In addition to young age, other donor characteristics, such as first-time donation status and estimated blood volume, independently predict complications after whole blood donation [1], [2], [3], [15], [16], [17], [18], [19]. About 2% to 5% of all presenting donors and about 5% to 10% of donors younger than 19 years experience presyncope as the sudden onset of dizziness, lightheadedness, pallor, or other symptoms that usually resolve promptly but are still unpleasant for the donor [1]. Less commonly, syncope (ie, loss of consciousness) occurs in about 4 in 1000 donations, and injury results in about 0.6 per 1000 donations, among donors aged 16 to 17 years [1], [3]. This incidence of syncope and related injuries in the youngest donors is significantly higher than the rate observed in matched groups (eg, age, sex, and donation experience) of older donors [3]. Moreover, almost half of all injuries that occurred at collection sites in 9 ARC regions involved 16- to 17-year-old whole blood donors, and some (eg, concussions, lacerations, dental injuries, and a broken jaw) were severe enough to require urgent medical care [3]. Even minor reactions or temporary deferrals discourage individuals from donating blood again and, not surprisingly, syncope and injuries more profoundly dampen return donation rates [3], [20], [21], [22], [23].

The underlying mechanisms for the increased susceptibility to presyncopal symptoms and syncope among young donors are not clearly defined but likely have both physiologic and psychologic triggers [24]. The term “vasovagal” is often used to describe reactions after whole blood donation, although blood pressure changes are rarely documented during the acute onset of symptoms. More general terms such as presyncopal symptoms or syncope will be used in this review. Presyncopal symptoms (eg, dizziness and lightheadedness) and syncope (ie, loss of consciousness) may result from the direct effect of acute hypovolemia, psychologic stress, and changes in vasovagal tone or orthostatic blood pressure changes after donation [24]. Different blood centers define reactions based the use of various definitions to characterize severity (eg, light, moderate, and severe) or reaction types (eg, presyncope or prefaint, syncope, short or long loss of consciousness, falls, or injuries) observed by collection staff or reported to the center [15]. The lack of standardization precludes direct comparison of results across blood centers, but an individual blood center that uses standard definitions, training, and procedures can track reaction trends over time. Alternatively, a survey tool, the Blood Donation Reactions Inventory (BDRI), captures donors' subjective ratings of presyncopal symptoms after blood donation and has been used as the primary outcome measure in several intervention studies [25].

Although the proportion of blood donors who experience a reaction or faint (0.1%-0.4%) is small, many individuals are affected, considering the total number of blood donations each year and the escalating recruitment of young blood donors. By similar reasoning, even a relatively small reduction (eg, 10%-20%) in the rates of adverse reactions would mean a better donation experience for thousands of individuals each year, especially on high school and college drives. Consequently, blood centers strive to identify ways to improve the donation experience and reduce the risk of complications, not only to safeguard donors' health and well-being but also to encourage return donation over the long term.

To reduce reactions among young whole blood donors, blood centers have recently applied the strategies that are supported by controlled trials and have monitored the effectiveness of the measures in practice [1], [2]. Operational tactics to improve donation safety aim to recruit donors less likely to have reactions, to modify the drive environment, or to use automated (apheresis) procedures instead of whole blood collection. Physiologic strategies may reduce an individual blood donor's risk of a reaction, such as having the donor drink water shortly before the phlebotomy or performing applied muscle tension (AMT) maneuvers. Psychologic aspects of the donation experience may be addressed by gauging donors' fear and anxiety, providing donors with information about coping strategies before blood donation, or distracting their attention during the phlebotomy. In 2008, an AABB Task Force recommended that blood centers adopt 1 or more of the measures in Table 1 to reduce reactions among young donors and develop monitoring programs to continually assess donation safety [26]. The measures are supported to varying degrees by randomized or controlled trials or by observational data and predictive models (Table 2, Table 3, Table 4) [1], [2], [15], [16], [17], [18], [19], [27], [28], [29], [30], [31]. This review examines the available data that support the use of individual interventions and the recent efforts by ARC and the Blood Systems, Inc (BSI), on the practical application of various strategies in combination, to reduce the risk of syncopal reactions among young blood donors. Future directions for research should explore other possible ways to predict and prevent syncope, injuries, and delayed reactions.

Table 1. Strategies to Reduce Reactions Among Young Blood Donors [26]
Predonation education
Drive setup and environment
Staff supervision and phlebotomist skills
Selection criteria (eg, estimated blood volume) for whole blood donors
Automated red cell collection
Interventions
Water ingestion before donation and within 10-20 min of phlebotomy
Distraction during phlebotomy
Muscle tension during phlebotomy
Postreaction instructions to donors and parents
Table 2. Predictors of Presyncopal Symptoms and Syncopal Reactions
Risk factor (Reference)ReferenceRisk of reactions, adjusted odds ratio (95% CI)Percent of total reactionsPercent of total donations
First DonationTrouern-Trend et al [17]2.71 (2.13-3.46)NRNR
Wiltbank et al [18]2.80 (2.66-2.94)47%25%
Rios et al [19]1.95 (1.89-2.02)66%42%
Age (y)
17-20Trouern-Trend et al [17]4.01 (3.89-4.12NRNR
17-18Wiltbank et al [18]2.75 (2.56-2.94)27%10%
16-18Rios et al. [19]3.89 (3.78- 4.00)41%19%
Sex: femaleTrouern-Trend et al [17]1.21 (0.97-1.51) (NS)NRNR
Wiltbank et al [18]1.20 (1.10-1.31)75%58%
Rios et al [19]1.28 (1.23-1.33)68%54%
Weight: 110-120 lbTrouern-Trend et al [17]2.11 (2.13-3.46)NRNR
Wiltbank et al [18]NRNRNR
Rios et al [19]2.52 (2.38-2.67)7%3%
Estimated blood volume: <3500 mLTrouern-Trend et al [17]NRNRNR
Wiltbank et al [18]2.88 (2.57-3.23)13%5%
Rios et al [19]2.45 (2.29-2.61)All donors: 14.5% (Donors <23 y: 11%)All donors: 6% (Donors <23 y: 3%)

Abbreviations: NR, not reported; NS, not significant; CI, confidence interval.

Table 3. Controlled Interventional Trials to Reduce Reactions Among Young Donors
StudyStudy description and conclusionStudy groupsResultsEffect on reaction end point
Hanson and France [29]83 donors (43 men, 40 women); age, 18-26 y; randomized to predonation water (500 mL approximately 30 min before donation). Conclusion: mean BDRI scores between groups were significantly different.Water0.48 log units, BDRI⁎−47%
Control0.91 log units, BDRI
Newman et al [30]8894 whole blood donations (4340 in 2004; 4677 in 2005) by 17-19 y (age); assigned to predonation water (473 mL) or control; data were reanalyzed to correct for unequal assignments to groups. Conclusion: the rate of total vasovagal reactions recorded by staff at the collection sites was significantly different between groups.Water9.9 % reactions†−21%
Control12.5% reactions
Ditto et al [27]605 college-aged donors (mean age, ∼22 y) were assigned in consecutive blocks of 15-20 donors to AMT, control–no AMT, or placebo groups.
Conclusion: mean BDRI scores were not different among the groups overall or for male participants. Significantly lower BDRI scores were reported for female donors in AMT group compared with control or placebo groups.		AMTFemale donors: 0.44 log units, BDRIAMT vs control or placebo, -21%
Control (no AMT)Female donors: 0.56 log units, BDRI
PlaceboFemale donors 0.58 log units, BDRI
Ditto et al [28]1209 college-aged blood donors (mean age, 22 years) to 1 of 5 conditions involving tension of different muscle groups or donation as usual.
Conclusion: Mean BDRI scores were significantly different among donors in full-AMT condition compared with the control (no AMT) group.
Significant differences were also observed in the entire body, lower body, and upper body with distraction groups compared with the control (no treatment) arms.		Entire body (full) AMT0.42 log units BDRIFull-AMT or lower body AMT vs No AMT, −19%
Upper body AMT0.45 log units, BDRI (NS vs control)
Lower body AMT0.42 log units, BDRI
Upper body AMT + distraction0.41 log units, BDRI
Needle-arm AMT (expectation/placebo group)0.47 log units, BDRI (NS vs control)
Control (no AMT)0.52 log units, BDRI
France et al [31]414 college-aged blood donors (214 women, 199 men) (mean age, 20.2 y) were randomized to 4 groups: standard donation, placebo (leg exercise before venipuncture), predonation water, or predonation water and leg exercise.
Conclusion: Main effects of group were observed for phlebotomist classification of vasovagal reaction and donor reports of presyncopal reactions.
Mean BDRI scores were significantly different for female donors in the water-only and water-plus-leg-exercise group compared with either the standard donation or the placebo groups.		Standard donation (Female donors, n = 53) Group compared with standard donation:
Female donors, 10.3 log units, BDRI
Placebo (leg exercise before venipuncture; Female donors, n = 53)
Female donors, 10.6 log units, BDRI+3%
Predonation water (Female donors, n = 55)
Female donors, 6.4 log units, BDRI−36%
Predonation water and leg exercise (Female donors, n = 54)
Female donors 5.3 log units, BDRI−49%

Abbreviation: NS, not significant.

⁎BDRI, mean scores (donor survey tool to calculate score based on self-reported measures such as faintness, dizziness, and weakness).

†Based on staff documentation of all “vasovagal reactions” (eg, prefaint symptoms, loss of consciousness) at the collection site.

Table 4. Observational Studies to Reduce Reactions Among Young Donors
StudyStudy descriptionStudy groupsTotal reaction⁎ rateEffect on reactions
Tomasulo et al [2]Prospective, observational study
213 031 allogeneic whole blood donations (age, 17-22 y) before and after implementing the following measures:		All donors, 17-22 y Before: n= 99,859All donors, 17-22 y Before: 3.3%−24%
1. Selection of donors with estimated total BV ≥3500 mL based on Nadler equationAfter: n= 113,172

After: 2.5%

2. Predonation water
3. Muscle tensing exercises†Female donors;17-22 yBefore: n = 64 015After: n = 63 526Female donors; 17-22 yBefore: 4.0%After: 3.2%−20%
Eder et al [1]Prospective observational study
710 922 allogeneic whole blood donations (age, 16-18 y; including 143 948 donors aged 16 y) in 2009 school year		All donors, 16-18 yAll donors, 16-18 y−20%‡

Baseline: n = 2 019 599

Baseline: 8.8%
Comparison of baseline period (2005-7 school years) toTransition: n = 754 402Transition: 8.0%
Study: n = 710 922
Transition (2008) period:Female donors, 16 yStudy: 7.1%
Baseline: n = 93 942
Study (2009) period: selection of donors with estimated total BV ≥3500 mL based on Nadler equationTransition: n = 80 374Female donors, 16 y−26%‡
Baseline: 12.9%
Study: n = 73 128Transition: 11.0%
Study: 9.5%

Abbreviation: BV, blood volume.

⁎Total reactions included staff documentation of presyncope and syncopal reactions at the collection site.

†Donors were instructed to tense the major muscles in the legs and buttocks and sustain the tension for 5-second intervals at the beginning of phlebotomy while alternating with 5 seconds of relaxation.

‡Study period vs baseline period. ⁎⁎ Predonation education, staff supervision, standard drive guidance including predonation water (16 oz) and muscle tension advice (alternate, repetitive leg lifting).

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Before the Donation—Donor Education and Drive Environment 

The importance of educating prospective donors about what to expect during a blood donation and how to manage symptoms should they occur is usually recognized but often underappreciated as part of an effective preventive strategy. Blood centers provide prospective donors with information about blood donation and the need for blood in the community to motivate them to donate. The educational materials in the AABB's Donor History Questionnaire instruct donors about infectious diseases such as human immunodeficiency virus and hepatitis C virus, high-risk behaviors, and the screening process to protect transfusion recipients [32]. Prospective blood donors should also be informed about the donation process and the potential risks to their health and should be provided with information about preparing for the phlebotomy and precautions to reduce the risk of reactions [33], [34].

Educational materials that directly address prospective donor concerns and provide specific coping suggestions may enhance donation attitudes and intentions to give blood [35], [36]. France and colleagues [36] empirically tested 3 recruitment brochures in a randomized study of young, novice blood donors. They compared the standard brochure used by the blood center or a control brochure with information unrelated to blood donation to a study brochure that specifically addressed donors' concerns about fear, pain, and potential vasovagal complications and contained specific instructions about fluid loading, applied muscle tensing, and distraction. The study brochure was associated with improved scores on questionnaires that assessed the donors' attitude, anxiety, perceived ability to cope with donation (ie, self-efficacy), and intention to donate [36].

Donation-related fears are most apparent among young, novice donors, and anxiety contributes to the risk of fainting [37]. Distraction techniques put some donors at ease during blood collection, depending on their preferred method of coping. Individuals described as “blunters” tend to use denial, distraction, and reinterpretation to deal with stressful procedures; in contrast, “monitors” tend to seek relevant information and attend to the situation [38]. Bonk and colleagues [38] randomized 112 college-aged (mean, 19 years) blood donors to a distraction group or a standard donation group and evaluated self-reported symptoms after donation using the BDRI and assessed donors in each group for their coping styles using a standard behavioral scale. Audiovisual distraction was associated with improved scores on the BDRI and reduced reporting of vasovagal symptoms by donors with blunting coping styles but not by donors with monitoring coping styles. This study reveals that a standard, “one-size-fits-all” approach may not work for all blood donors. Taking individual preferences into account, if the evaluation could be quickly and easily accomplished on a busy blood drive, may target certain preventive measures to the most susceptible donors. Although the risk of fainting or syncope-related injuries was not evaluated in these studies, the correlation of fear with presyncopal symptoms and the positive effects of education and distraction on self-reported symptoms suggest that interventions that alleviate anxiety may translate into substantively improved safety for young blood donors.

A controlled environment on a mobile drive is essential for a good donation experience for all blood donors, regardless of their age, although few studies have evaluated the possible effect of the drive setup or environment on donor reactions. Also widely acknowledged but rarely systematically studied is the contribution of an experienced phlebotomy staff and adequate supervision to safe operations on a drive. The high school gym or cafeteria, in particular, presents special challenges for mobile staff and often showcases the psychologic factors that influence donor reactions, especially among adolescents. Serial or “epidemic” fainting is usually described in the setting of a busy blood drive, when young, anxious donors faint at the sight of other fainting donors [15]. Collection staff must quickly identify and treat donors having reactions but also must control the situation and handle other donors on the drive. Limited evidence supports the conclusion that phlebotomists' interpersonal skills are inversely correlated with the likelihood of adverse donor reactions [39].

Similarly, the available data and accumulated experience support the importance of a controlled environment on high school drives [1], [40]. The ARC developed standard guidance for staff, materials, and equipment and work sequence on high school drives. Four Red Cross regional blood centers evaluated the operational changes in a pilot study in 2008, before systemwide implementation. The key aspects addressed the number of beds and interview areas for the expected number of donors, outlined the layouts for drive setup, moved the waiting areas out of view of the phlebotomy beds, and defined a standard collection process from reception to the recovery area. The standard work process on high school blood drives was associated with a significantly decreased rate of presyncopal reactions among 16- and 17-year-old donors in 3 of the 4 regions that implemented the operational changes [40]. The benefit appeared limited to female donors. Although this observational study was relatively small and limited in scope, the data support the importance of a controlled environment on high school drives to reduce reactions and enable more efficient donor flow through the process.

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Donor Selection Criteria and Predictive Models 

Several studies have used statistical methods including multivariate logistic regression analysis to identify the factors that are associated with syncopal reactions and further delineate the relative contribution of each variable to the overall risk (Table 2). By identifying the factors that are most strongly associated with reactions, preventive measures, such as educational efforts, procedural modifications, or exclusionary policies, can be focused on the donor groups at greatest risk for complications. Unfortunately, the predictive value of individual donor characteristics for donor reactions is generally low, and no single factor is sensitive or specific enough to eliminate most reactions. Consequently, restrictive selection criteria to exclude groups of donors at greater risk of reactions should critically balance the possible benefit against its effect on the donor base.

Based on data from several predictive models, one of the strongest independent risk factors for syncopal reactions is the donors' total estimated blood volume. Healthy people can usually tolerate the acute loss of about 10% to 15% of their blood volume, which has traditionally defined the upper limit for whole blood collection volume that should not be exceeded because of an unacceptable risk of syncope. The Council of Europe pragmatically defines 13% of a donors' estimated total blood volume as the acceptable limit for a whole blood collection [41]. The AABB Standards for minimum donor weight (50 kg or 110 lb) and maximum collection volume (10.5 mL/kg) are intended to limit blood loss to no more than 15% of a person's total blood volume with a standard whole blood donation (∼525 mL) and protect most but not all of the most vulnerable donors [42]. These criteria are based on conventional estimates of 70 mL of whole blood per kilogram of body weight, which correspond to a minimum estimated total blood volume of 3,500 mL for donors at the lower weight limit. Using only the donors' reported weight to estimate total blood volume, however, may not be as precise as other methods, such as the formula developed by Nadler et al [43], which takes into account sex and height, as well as weight.

Applying the Nadler equation, Wiltbank et al [18] and Kamel et al [44] reported that as many as 5% of donors in their blood centers had an estimated blood volume less than 3500 mL but disproportionately accounted for 13% of vasovagal-type reactions at the collection site (Table 2). Kamel and colleagues [44] further reported that low blood volume is also a powerful predictor of delayed, moderate and severe vasovagal reactions. The authors estimated that changing policy to exclude donors younger than 23 years with blood volume less than 3500 mL would affect about 9% of current donors in this age group (1.6% of all donors) across their system, while preventing about 20% of moderate and severe reactions in this age group (9% of all reactions) [26], [44]. Likewise, data from 2 ARC blood centers suggested that about 3% of donors younger than 23 years had an estimated blood volume less than 3500 mL but accounted for about 9% of presyncopal reactions and 11% of syncope-related complications [19]. The ARC predicted that requiring donors in the youngest age group (16-18 years) to have an estimated blood volume of at least 3500 mL would prevent about 10% to 15% of presyncopal and syncope-related complications in this age group without adversely affecting the adequacy of the blood supply. Although the effect of any given change in selection criteria can be estimated by multivariate analysis, implementation may or may not achieve the predicted results because of other variables or unexpected changes in the system. As explored below, however, the modeled predictions were largely realized in observational studies at ARC and BSI.

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Controlled Intervention Trials: Predonation Water and AMT 

Applied muscle tension and acute water loading avert or reduce syncopal reactions experienced by susceptible patients with neurocardiogenic syncope and individuals with blood or injury phobias. Research on the benefit of the techniques in these clinical settings and physiologic laboratories has led to their application in blood donation [24]. Both interventions likely prevent presyncopal symptoms and syncope by attenuating blood pressure changes with whole blood donation, acting through different physiologic pathways [24]. The behavioral technique of AMT, which involves the repetitive contraction of major muscle groups of the arms and legs, promotes venous return and cardiac output and affects cerebral blood flow. In a study of 72 whole blood donations, women who performed AMT maneuvers demonstrated less of a decrease in cerebral blood flow after donation than those who did not perform the exercises [45]. The study was not sufficiently powered to assess differences in the rate of reactions between the groups or to correlate reported symptoms with measured oxygenation changes. Regardless, the findings suggest a possible mechanism for the salutary effect of AMT on presyncopal reactions. Similarly, acute water loading increases blood pressure, peripheral vascular resistance, and cerebral blood flow in patients with autonomic dysfunction, older individuals, and healthy subjects undergoing orthostatic challenge in the laboratory (eg, tilt table tests). The transient pressor effects of acute water loading have been attributed to gastric distension and increased sympathetic tone and total peripheral resistance [24].

The use of AMT in the setting of blood donation is supported by several, relatively small controlled trials (Table 3). Ditto and colleagues [27] assigned 605 donors at mobile blood drives to an AMT treatment condition, or a no-treatment control condition, or a placebo control condition. Group assignments were made by having 15 to 20 consecutive donors participate in 1 of the 3 arms. For the AMT treatment condition, donors were instructed to tense the major muscle groups in their arms and legs at 5-second intervals while breathing steadily, before and during the phlebotomy. The placebo condition instructed donors to practice the technique only before the insertion of the needle without being told that reactions are unlikely during this period. The outcome measures were BDRI symptom scores reported by the donors and whether or not the nurse reclined the chair, presumably to treat a reaction. To facilitate comparison across studies in this review, only the BDRI symptom scores are further considered and not the chair reclining end point or other interventions by staff used as surrogate or indirect markers for possible donor reactions. There were no differences in BDRI scores between groups for male donors. Women assigned to the AMT condition reported significantly fewer donation-related symptoms than did women in either the control or placebo groups [27]. The magnitude of the effect for female blood donors was about a 20% improvement in BDRI scores.

Ditto and colleagues [28] extended their study of applied tension during blood donation, in a randomized controlled trial that assigned 1209 college-aged blood donors (mean age, 22 years) to 1 of 5 conditions involving tension of different muscle groups or donation as usual. Donors in the full-AMT group performed repeated 5-second cycles of whole-body isometric muscle tension while maintaining steady breathing while in the donation chair. The 4 variations on AMT included lower body tension, upper body tension with or without distraction away from the arm with the needle, and an expectation/placebo group that performed needle-arm AMT (tensing the needle arm only to improve blood flow). Donors in full-AMT group, lower body AMT, and upper body with distraction groups reported significantly fewer symptoms on the BDRI compared with the control (no AMT) group [28]. The difference between the upper body AMT and expectation/placebo group was not significantly different from the control group. The authors concluded that the lower body tension and distraction likely contribute to the benefit observed with AMT.

Three published, controlled studies have evaluated the effects of drinking water shortly before the phlebotomy (Table 3) [29], [30], [31]. Hanson and France [29] randomized 83 male and female, first-time donors (mean age, 20 years) to drink 500 mL of water approximately 30 minutes before allogeneic whole blood donation or to a control group that did not receive water before donation. Drinking water before donation did not affect the donors' chronic hydration status, as measured by bioimpedance analysis. Using BDRI scores as the primary outcome measure, donors who received water reported significantly fewer presyncopal reactions (eg, faintness, dizziness, and weakness) compared with those in the control group.

Newman et al [30] described their experience in a regional ARC blood center in 2 consecutive years with nearly 9000 high school students (17-19 years of age) who were given about 16 oz of water to drink within about 30 minutes before whole blood donation. The authors reported that water ingestion decreased vasovagal reactions observed by collection staff at the drive by 21% (water group, 9.9% reactions; control group, 12.5% reactions). A reduction in reactions was observed for both male and female donors. Additional analysis of selected data demonstrated that the reaction rates were lowest for those who consumed water within 10 minutes of the phlebotomy, and the effect waned until the differences between the groups were eliminated by 30 minutes [30].

The largest, randomized controlled trial to date evaluated both predonation water and AMT [31]. France et al randomly assigned 414 college-aged blood donors (214 women, 199 men) to 4 groups: standard donation, placebo (leg exercise before venipuncture), predonation water, or predonation water and leg exercise. Based on phlebotomist classification of reactions, donors in the predonation water or predonation water and leg exercise groups had fewer reactions compared with the placebo but not compared with standard donation. The analysis of self-reported symptoms on the BDRI revealed that women, but not men, had lower scores in both the predonation water and the predonation water and leg exercise groups, compared with either placebo or standard donation (Table 3).

These controlled trials support the benefit of a predonation water drink and the use of muscle tension exercises in reducing staff-observed vasovagal reactions or donor-reported presyncopal symptoms by at least 20%. Although the research findings are consistent and promising, several limitations warrant consideration. The studies did not evaluate the extent to which these measures may affect the risk of syncope, injuries or delayed reactions. Blood Donation Reactions Inventory scores capture the donors' subjective ratings of symptoms experienced during a blood donation and have been shown to correlate with the likelihood of donor return [25]. Using the BDRI scores as an outcome measure avoids the potential variability associated with recognition and reporting of reactions by collection staff. However, the relationship of BDRI scores to the risk of syncope or medically relevant injuries is assumed but unproven. Ideally, researchers should use not only presyncopal symptoms or total reactions but also more objective and direct measures of serious potential harms such as syncope as a primary outcome measure in controlled trials. This expectation, however, requires much larger studies that could prove to be too prohibitive for enrollment or too disruptive to normal blood center operations. Finally, the extent to which the conclusions derived from a research setting can be generalized to field blood drives is also uncertain when incomplete compliance with behavioral recommendations or partial application of the measures may reduce their effectiveness on busy high school drives.

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Putting evidence into practice for young blood donors 

Motivated by the data from controlled trials and predictive models and facing the increasing recruitment on high school and college drives, ARC and BSI independently made operational changes in their standard practice in an effort to reduce syncopal reactions among young whole blood donors [1], [2]. Both groups reinforced guidance for a predonation water drink and muscle tension exercises during donation to reduce reaction rates in susceptible donor groups and applied new selection criteria for estimated blood volume using the Nadler equation. Eligible donors had at least 3500 mL total estimated blood volume, to limit blood loss with whole blood donation (∼525 mL) to less than 15% of their total blood volume. The ARC screened donors aged 16 to 18 years and donors on high school drives; BSI targeted donors aged 17 to 22 years. Both organizations systematically collected data on presyncopal symptoms and syncopal reactions at the collection sites before and after implementing the measures to evaluate their effectiveness in practice. In both prospective observational studies, blood center staff collected data on reactions concurrently on the day of the donation in each time period as part of the organizations' standard practice to monitor donor reactions.

Tomasulo and colleagues [2] at BSI reported on 213 031 allogeneic whole blood donations made by 17- to 22-year-old donors in 2 separate 12-month time periods before and after implementing measures to reduce reactions. The changes included (1) selecting donors with estimated total blood volume of at least 3500 mL based on the Nadler equation, (2) encouraging AMT during donation, and (3) providing approximately 500 mL of water before donation. The interventions decreased the aggregate reaction rates in male and female donors by 24% (Table 4). In addition, the measures were associated with a 25% decrease in delayed reactions occurring more than 4 minutes after the phlebotomy was completed and a 38% decrease in off-site reactions among female donors. The water and muscle tension interventions were evaluated in a separate analysis of donors with total estimated blood volume greater than 3500 mL and were associated with a smaller reduction in reactions than the measures combined with the selection criteria. The authors eliminated the possibility that the overall improvement reflected a change in the donor demographics unrelated to blood volume differences by separately evaluating 17- to 22-year-old white, female donors. In this stratified analysis, the rate of reactions significantly decreased after implementing the selection criteria and operational changes in first-time and repeat donors for all outcomes, except falls. Falls were infrequent in all donor groups, occurring at a rate of 1.4 per 1000 donations before the interventions. A nonsignificant increase in falls occurred after the interventions among female, white donors at their first donation but not at repeat donations. Multivariate analysis clearly showed that the interventions decreased the occurrence of reactions in susceptible groups, but the known risk factors (young age, first-time donation status) still exerted unfavorable effects and remained associated with relatively higher reaction rates [2].

In parallel, Eder and colleagues [1] described the ARC experience with a similar safety initiative for young whole blood donors. The selection criteria for estimated total blood volume and other measures were introduced for donors aged 16 to 18 years, and reaction rates were compared during the 9-month school year (September-May) in different time frames: baseline, transition, and study period (Table 4). The transition period introduced changes to the predonation educational material to provide additional information about preparing for a whole blood donation and standard guidance for staffing, materials, and equipment on a high school drive, as previously described for the pilot study [40]. The standard drive guidance also included recommendations to encourage all donors to drink a 16-oz bottle of water shortly before the phlebotomy and to remain in the recovery area for about 15 minutes after the donation. These measures were implemented at different times in ARC blood centers during the transitional period and were associated with a reduction in overall reaction rates, although the youngest donors still had the highest risk of reactions in the analysis stratified for age, sex, and donation status.

In contrast, all 35 regions of ARC simultaneously introduced the new selection criteria for blood volume on September 1, 2009, in the study period. After implementation, reactions among 16- to 18-year-old donors decreased by 18% to 33% compared with baseline years and 9% to 18%, compared with the transition school year. The benefit was most pronounced for the youngest donors, and 16-year-olds not only had fewer presyncopal reactions but also had significantly decreased rates of syncope compared with the baseline period. The blood volume selection criteria effectively moderated the influence of age on the reaction rate, such that 16- and 17-year-old blood donors were at comparable risk of reactions as unselected 19- and 20-year-old blood donors in the study period but significantly higher risk in the transition and baseline periods. Although the contribution of the education, drive guidance, water, and muscle tension interventions could not be separately assessed in the transition period, the blood volume selection criteria made the strongest contribution to the decreased reaction rates observed in 16- to18-year-old donors. Full compliance with the water and muscle tension guidance was only 52% and 22%, respectively, among about 24,000 surveyed 16- and 17-year-olds in the study period, which may have limited the contribution of these interventions.

In conclusion, the data from ARC and BSI independently support the benefit of the selection criteria for blood volume to mitigate reactions among young donors, largely to the extent predicted by statistical models. In both reports, the aggregate effect of the selection criteria for estimated blood volume reduced the reactions by at least 20%. As expected, the measures did not completely eliminate the risk of reactions after whole blood donation. Moreover, selecting for total blood volume markedly reduced but did not completely eliminate the influence of other factors known to be associated with increased risk of syncopal reactions, such as young age and first-time donation status. Both organizations also reported that the inconsistent or incomplete use of water loading and AMT may have limited the effectiveness of these interventions.

Notably, both studies observed a low rate of falls or injuries at the collection sites in all donor groups and study periods but a marginal increase that did not reach statistical significance after introducing the operational changes. In fact, no study to date has yet demonstrated a significant effect of a preventive measure on the risk of the rare but potentially serious injuries resulting from syncope after whole blood donation. Conceivably, the studies may have failed to detect a significant difference by chance, or there may have been no difference in fall or injury rates after introducing the operational changes. The sample size in the Red Cross study was sufficient to detect a 20% difference in the rate of injuries at a 5% significance level, and 80% chance of detecting a difference but would not be sufficient to detect a smaller difference between groups. Although the selection criteria for blood volume were predicted to reduce the risk of both syncope and syncope-related falls or injuries, another change during the study period may have counteracted any measurable benefit. Further study to delineate the circumstances surrounding the recorded injuries at the collection sites may identify possible contributing or mitigating factors and suggest additional preventive measures. Alternatively, syncope-related falls and injuries may be too uncommon, idiosyncratic, or unpredictable to use as an outcome measure, even in large observational studies.

Regardless, ARC and BSI have demonstrated that the blood volume selection criteria and other measures reduce the risk of presyncopal symptoms and syncopal reactions at the collection sites and provide a better donation experience for many young donors each school year. Furthermore, the measures will likely improve efficiency on drives with less disruption from reactions and encourage return donation, as well. Donor retention should be studied over a longer period of time to confirm that donors who have uneventful donations at a young age are more likely to continue to donate into adulthood.

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Future Directions 

Blood centers have the dual responsibility to provide an adequate blood supply to the community and protect the health of volunteer blood donors. Efforts to improve donation safety for young blood donors should translate the available evidence into practice and evaluate the effectiveness of the interventions. Further systematic study could identify alternative means to achieve similar benefit or additional ways to further improve the donation experience. Both ARC and BSI demonstrated that new selection criteria for estimated blood volume were feasible and successful, having little effect on total collections and leading to significantly reduced presyncopal and syncopal reactions among young, whole blood donors. Comparable results may be achieved by collecting no more than 450 mL of whole blood or 10% of total blood volume from young donors, although there are no experimental data to support this assumption [15]. Another plausible approach that has not yet been tested is the possible benefit of dietary salt supplementation in addition to water ingestion, to restore and stabilize plasma volume for a prolonged (> 1 day) period of time after blood donation [24].

Automated (apheresis) red cell collection procedures (eg, 2-unit red blood cells, or double red cell collections) offer an alternative to whole blood collections and have a favorable safety profile [4], [46], [47], [48]. The ARC demonstrated that automated 2-unit red blood cell collection procedures for 17- to 19-year-old donors were less likely to involve major systemic complications at the collection sites compared with whole blood donation, before introducing the blood volume restrictions for young whole blood donors [48]. The benefit was most pronounced among young and first-time donors and is likely attributed to intravenous fluid replacement or the more stringent donor selection criteria that favored automated procedures. Notably, systemic reaction rates after whole blood donation or automated red cell collection were more comparable after introducing the new selection criteria for total blood volume for whole blood donation (ARC Hemovigilance Program, data not shown). This finding further supports the benefit of measures to limit blood loss after whole blood donation to less than 15% of the donors' estimated total blood volume. Not addressed in these studies, however, is the issue of iron balance in young blood donors and the risk of iron depletion and anemia, either by automated procedures or by whole blood donation, which deserves special attention in adolescents who have particular iron requirements for development and growth.

If blood centers could more accurately predict which individual donors were likely to have a reaction after whole blood donation, they could better target specific interventions to those donors most likely to benefit. Blood centers currently rely on a standard approach to screen or treat all presenting blood donors to minimize the potential for error in a highly regulated environment. Admittedly, the current approach to exclude donors at a relatively greater risk of reactions, or to use the same interventions for every donor, is a blunt approach when the risk predictions are not precise and the response of all donors is not uniform. In their small study of 210 Japanese blood donors, Ando and colleagues [49] suggested that a simple standing test before and after whole blood donation detected heart rate changes that correlated with the risk of vasovagal reactions. This screening test may identify donors who are more likely to respond to a water drink before phlebotomy. Bravo et al [50] have also investigated the factors associated with fainting across defined periods of the donation process, including syncope before venipuncture. Their findings suggest that different mechanisms (eg, psychologic and relative hypovolemia) contribute to reactions in different phases of the donation such that more targeted interventions could be designed and tested to reduce the risk of syncope and injury across the entire the donation process. Finally, France and colleagues [51] show that assessment of donors' fear or anxiety before the donation may also lead to better prediction of reactions and more effective utilization of specific interventions, such as water ingestion or AMT for the most susceptible donors.

Future studies should focus on objective end points (eg, syncope) to the extent possible and should extend the evaluation beyond the immediate postdonation period to include delayed reactions, both of which contribute to a greater risk of injury. Although the risk to donors cannot be completely eliminated, encouraging results show that safety can be significantly improved. Recent measures taken by ARC and BSI reflect their commitment to make the donation process as safe as possible for volunteer blood donors, especially the youngest and most susceptible donor group. A better donation experience will undoubtedly benefit both the individual blood donor and the community blood supply.

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PII: S0887-7963(11)00067-8

doi:10.1016/j.tmrv.2011.07.008

Transfusion Medicine Reviews
Volume 26, Issue 1 , Pages 14-26, January 2012

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