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 Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 6  |  Issue : 4  |  Page : 148-153

Prevalence of acute adverse reactions among whole blood donors: A 7 years study


Department of Transfusion Medicine, Gian Sagar Medical College, Patiala, Punjab, India

Date of Web Publication16-Dec-2015

Correspondence Address:
Sonam Kumari
H. No. 120, Sector 20 A, Chandigarh - 160 020
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1658-5127.171989

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  Abstract 

Background: Donor reaction has the most negative impact on the blood donor return rate. Amelioration of some adverse events has the potential to improve return rate. This study was initiated with the aim to determine the frequency of various adverse reactions. Materials and Methods: The study was conducted over a period of 7 years and 1 month, from July 1, 2007, to August 31, 2014. The donor population analyzed consisted of 27,664 donors (26,557 males and 1107 females). Results: Only 195 donors (0.7%) suffered some adverse reactions. One hundred and fifty-eight (0.57% of the subjects) had mild reactions (agitation, sweating, giddiness, pallor, cold feeling, sense of weakness, nausea), and only 37 (0.13% with 10 females and 27 males) had more severe reactions (including vomiting, fainting, loss of consciousness, and convulsive syncope). Conclusions: Although the number of donors who developed adverse reactions during or immediately after the blood donation was very low, still it is very important to reduce risks to a minimum so that donor return rate could be maintained.

Keywords: Adverse reactions, blood donations, blood donors


How to cite this article:
Kumari S. Prevalence of acute adverse reactions among whole blood donors: A 7 years study. J Appl Hematol 2015;6:148-53

How to cite this URL:
Kumari S. Prevalence of acute adverse reactions among whole blood donors: A 7 years study. J Appl Hematol [serial online] 2015 [cited 2019 Jun 18];6:148-53. Available from: http://www.jahjournal.org/text.asp?2015/6/4/148/171989


  Introduction Top


Blood donors normally tolerate the donation very well, but occasionally adverse reactions of variable severity may occur during or at the end of the collection. An adverse event was defined as the symptoms or signs of donor discomfort of sufficient severity such that either the donor called for the attention of staff or they were noticed by staff while pain at the time of venipuncture was excluded.[1] Donor reaction had the most negative impact on the blood donor return rate. Amelioration of some adverse events has the potential to improve return rate.[2] Complications during blood donation have the strongest association with younger age group followed by the 1st-time donation status and female sex.[3] Studies have shown that donor reactions are associated with lower donor return. They cause discomfort, anxiety, and embarrassment to the donors who develop the adverse reaction along with apprehension, anxiety, and fear among the donors who are looking for the donation.

Adverse responses to donation can be (1) acute: Immediate or delayed (after single donation) (2) chronic: In response to long-term donation. Acute reactions most frequently arise from anxiety about painful venipuncture or due to blood volume deficit during donation. The most common type of acute reaction during or immediately after blood donation is a vasovagal reaction that can progress to syncope resulting in fall which can cause injuries.[4] Hematomas, thrombophlebitis, infection, and physical damage to nerve, tendons, or muscles are possible adverse effects of blood donation and can present as immediate or delayed complications. Nerve damage can present with numbness, tingling, radiating pain, with occasional loss of strength but since peripheral nerves can regenerate and heal; total recovery occurs in over 90%, but it can take a prolonged time.[4] Chronic adverse reactions such as iron depletion can occur in regular voluntary donors which commonly results in iron deficiency anemia.

The adverse reactions in blood donors can also be divided into local reactions and systemic reactions. Local reactions occur predominantly because of problems related to venous access. They are usually hematomas due to extravasation from the veins, caused by incorrect placement of the needle during the venipuncture.[5],[6] Pain, hyperemia, and swelling may develop at the site of the extravasation. The systemic reactions are usually vasovagal reactions, which can be triggered by the pain of the venipuncture, by the donor seeing his or her own blood, by the donor seeing another donor unwell, by the anxiety and state of tension of undergoing the donation, etc. They are characterized by the appearance of pallor, sweating, dizziness, gastrointestinal disorders, nausea, hypotension, and bradycardia. Therapeutic intervention must be swift; otherwise, vasovagal reaction at times progresses into syncope which may or may not be complicated by the onset of tonic-clonic muscle spasms (convulsive syncope), vomiting, loss of sphincter control sudden fall, and injuries.

Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors.[7] With this motive, this study was undertaken to estimate the frequency and type of adverse events and distinguishing mild reactions from more severe reactions.


  Materials and Methods Top


The study was a retrospective, epidemiological descriptive study. It was conducted over a period of 7 years and 1 month, from July 1, 2007, to August 31, 2014, in the Department of Transfusion Medicine of a 626-bedded Tertiary Care Educational and Charitable Hospital in Northern India.

Criteria for the selection of whole blood donors and the donor questionnaire cum consent form were in accordance with the rules laid down in Drugs and Cosmetics Act, Ministry of Health and Family Welfare, Government of India.[8] After predonation counseling and screening, donors within the age group of 18–60 years were selected, and individual informed consent was obtained from the donor questionnaire cum consent form. Donors signatures were also taken on donor record register as a proof for accuracy and reliability of the records and data. All the donor records were maintained and stored in both the electronic and the file form indefinitely. Institutional approval was also obtained for the study.

The population analyzed in this study consisted of 27,664 whole blood donors with 16,507 voluntary donors and 11,157 replacement donors. Out of the total 27,664 donors, 26,557 (95.99% of the total) were males (15,461 voluntary and 11,096 replacement), and 1107 (4.00% of the total) females (1046 voluntary and 61 replacement) with male/female ratio being 24:1. Among the 27,664 blood donors, 17,314 (62.6%) were repeat donors with 16,594 male and 720 female and 10,350 (37.4%) were the 1st-time donors with 9963 male and 387 female.

Adverse reactions were arbitrarily divided into two groups mild and severe depending on the severity of signs and symptoms and the aggressiveness of the management required for relieving the symptoms. Donors developing adverse reactions were retained at the donation center in postdonation area and were kept under observation for 30–45 min or until their vital parameters returned to normal.


  Results Top


Vasovagal reaction was the most common of all adverse donor reactions, occurring in 0.46% of the total study population. Among the 27,664 donors, only 195 (with 164 males and 31 females) suffered some adverse reaction, accounting for 0.70% of all the subjects [Figure 1]. Among those who developed adverse reactions, 170 (1.52%) were replacement donors while 25 (0.151%) were voluntary donors. The frequency of adverse reactions among male donors is 0.62% and that among females is 2.8% [Table 1] while absolute frequency is shown in [Figure 1].
Figure 1: Adverse reactions during or immediately after whole blood donation

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Table 1: Distribution of adverse events between the 1st-time and repeat male and female donors

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The donors who had some kind of adverse reaction were divided into two groups: The first group consisted of subjects who had mild adverse reactions (agitation, sweating, pallor, dizziness, cold feeling, sense of weakness, nausea), and the second group consisted of the subjects who had severe adverse reactions (including vomiting, fainting, loss of consciousness, and convulsive syncope) [Figure 2].
Figure 2: Absolute frequency of mild or severe reactions, stratified by gender

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One hundred and fifty-eight (0.57%) of the subjects had mild adverse reactions (with 137 males and 21 females) while 37 (0.13%) had more severe disorders (with 27 males and 10 females). One hundred and twenty-seven donors (0.46%) suffered mild vasovagal reactions with symptoms of giddiness, sweating, nausea, and pallor while 5 donors (0.018%) suffered generalized weakness and 26 (0.09%) developed hematoma. Among donors who suffered severe adverse reactions, 30 donors (0.11%) developed vasovagal syncope with fainting, 5 (0.018%) had vomiting, and 2 (0.007%) donors developed convulsions. Total percent of adverse reactions among male and female donors is shown in [Figure 3]. Mild vasovagal reactions and syncope resulting in fainting are more common among female donors. Adverse reactions are more common in the 1st-time donors among both male and female [Table 1], and the vasovagal reactions are significantly more common among female donors (P < 0.05). Distribution of adverse events between the 1st time and repeat male and female donors is shown in [Table 1]. Adverse events between voluntary and replacement male and female donors are shown in [Table 2].
Figure 3: Percentage of adverse reactions among male and female donors

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Table 2: Distribution of adverse events between voluntary and replacement male and female donors

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Syncope occurred in 0.11% (30 donors) of the total donors, but episodes of convulsive syncope occurred in 0.007% (2 males out of 27,664 subjects) which resolved within 15–20 min, without there being any repercussions in the hours following the donation. Only 5 subjects (0.018%) developed a vasovagal reaction with vomiting, which resolved immediately.


  Discussion Top


We found the overall rate of complications related to blood donation to be very low. Blood donation is generally safe, but a variety of risks and complications does exist, the most common being vasovagal reactions.[9],[10],[11] Vasovagal reactions and syncope were significantly more common among females and the 1st-time donors in the present study. There was not a well-defined pathophysiological cause for the vasovagal reactions, but rather a set of neuropsychological factors. Traumatic venipuncture, compared to an easy one, is a strong determinant of a vasovagal reaction. A painful stimulus caused by venipuncture can lead to a vasovagal reaction. Sweating, in fact, causes a further decrease in blood pressure because of vasodilatation, with sequestration of the blood in splanchnic organs and stasis in the lower limbs, due to gravity. All this further lowers the already low blood pressure caused by the removal of blood during the donation. The result is a slight and temporary deficit in blood flow to the brain. Dizziness follows on from hypoxia and causes a sense of ill-being or a vasovagal reaction, which sometimes evolves into syncope in the absence of a swift therapeutic intervention.

Younger age, lower body weight and body mass index, lower predonation systolic and diastolic blood pressure, lower circulating blood volume, and higher pulse are the factors associated with higher vasovagal reaction rate. Furthermore, vasovagal reactions are more common in female donors, donors with less sleep, and more time since a meal.[12],[13],[14],[15] Adequate hydration before donation along with nutritional intake is considered an important preventive measure. Measures of blood and injury sensitivity, pain sensitivity, and anxiety were examined as potential predictors of syncope among blood donors.[16],[17] Even minor reactions or temporary deferrals discourage individuals from donating blood again. The blood donation reactions inventory is an effective method of assessing reactions that predict donor nonreturn and therefore, may be a useful addition to future studies aimed at enhancing donor satisfaction and retention.[18] 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 or recruiting individuals who are less likely to have adverse reactions. Physiologic strategies modulate the donors' response to blood loss, decreasing their susceptibility to a donation-related reaction.[19],[20] Identifying those subjects who are particularly anxious, making them comfortable by engaging them in conversation, or by distracting their attention from what is happening around reduces the incidence of adverse reactions. Recruiting more and more of repeat donors and excluding donors with low body weight and female donors, if blood stocks are sufficient, are few strategies for reducing adverse reaction rate. Moreover, allowing the donor to drink water before and after donation and a light meal within 2–3 h of donation reduces adverse reaction rate by preventing orthostatic hypotension.[21] The postdonation interview is a good tool for defining the blood donor's experience. It can also be used to evaluate and potentially improve blood donor safety and comfort.[22]

From literature, it was found that overall prevalence of adverse reactions among whole blood donors was quite variable. It was 1.43% in Wiltbank et al. study, 1.6% in Tondon et al. (from India), while it was 36% in Newman et al. study.[22],[23],[24] In the present study overall prevalence of adverse reactions was 0.7% which was quite low, similar to most of the studies from India. Mild signs and symptoms such as pallor, fatigue, and sweating were considered as mild adverse reaction by some physicians and blood bank staff while not by others, which results in wide variation in the overall prevalence rate. Moreover, it also depends on perception of the caretaking staff and the staff recording and maintaining the data.

Management of adverse donor reaction should be quick and prompt. If the donor has low blood pressure even after routine management of vasovagal reaction which occurs in very rare cases, then infuse fluids intravenous (normal saline, Ringer's lactate solution), corticosteroids can be administered in slow recovering donors. If the pulse is very weak and the heart rate is slow, atropine can be administered. If the clinical situation evolves into an episode of syncope/faint, place the donor in antishock position, with particular care taken to hyperextend the head, to ensure that the tongue did not obstruct the oropharynx and that the respiratory tract remained patent.[25] Monitor the donor and retain him or her at the donor site until vital signs return to normal.

In the present study, voluntary donors suffered more adverse reactions compared to replacement donors which was in contrast to the Agnihotri et al. study where replacement donors suffered more adverse reactions than voluntary donors.[26] The probable reason for this difference might be that most of the donors in the present study were voluntary and had donated in outdoor voluntary blood donation camps and providing environment (temperature, humidity) as hostile and comfortable as inside the blood bank was usually not possible. Moreover, in camps sight of donors suffering adverse reaction creates anxiety and apprehension in nearby donors, especially younger and the 1st-time donors increasing the overall reaction rate.

Deferral of younger donors with low-estimated blood volume offers a rational approach to protecting donors at greater risk of reactions without jeopardizing the adequacy of the blood supply.[27] Adverse events analysis helps in identifying the blood donors at risk of donor reactions and adopting appropriate donor motivational strategies, predonation counseling, and care during and after donation.[26]

Since the present study was a retrospective study carried over a 7 years period, few drawbacks were noticed, as if certain adverse reactions might not be registered and thus there's a possibility of them being missed in the data. Furthermore, signs and symptoms of certain adverse reactions use to be so mild, such as donor discomfort, anxiety, pallor, that they were not considered as adverse reaction by some physicians.


  Conclusions Top


Overall, the number of donors who developed adverse reactions during or immediately after the blood donation was very low, but vasovagal reactions whether mild or severe (progressing to syncope/faint) were significantly more common among female donors, also incidence of adverse reactions as such was more among 1st-time donors when compared to repeat donors. Avoiding semi-sitting position during the donation and reducing the amount of blood collected in apprehensive donors, especially female donors or donors with lower body weight, within the limits allowed by law (range 350/450 ± 10%) are some of the measures that can lower the already low incidence of adverse reactions among blood donors. Sex, age, body weight, donation status, and blood pressure none of these factors were predictive of a severe reaction.[28] The donor's physical experience has a significant impact on the willingness to return and donate blood; therefore, precautions to prevent or to manage the adverse reactions should be taken at the earliest.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest

 
  References Top

1.
Rutman RC, Dpasuale-Barrios S. Donor reactions. In: Green TS, Steckler D, editors. Donor Room Policies and Procedures. Arlington: American Association of Blood Banks; 1985. p. 81-90.  Back to cited text no. 1
    
2.
Newman BH, Newman DT, Ahmad R, Roth AJ. The effect of whole-blood donor adverse events on blood donor return rates. Transfusion 2006;46:1374-9.  Back to cited text no. 2
    
3.
Eder AF, Hillyer CD, Dy BA, Notari EP 4th, Benjamin RJ. Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds. JAMA 2008;299:2279-86.  Back to cited text no. 3
    
4.
Abhishekh B, Mayadevi S, Usha KC. Adverse reactions to blood donation. Innov J Med Health Sci 2013;3:158-60.  Back to cited text no. 4
    
5.
Ranasinghe E, Harrison JF. Bruising following blood donation, its management and the response and subsequent return rates of affected donors. Transfus Med 2000;10:113-6.  Back to cited text no. 5
    
6.
Newman B. Arm complications after manual whole blood donation and their impact. Transfus Med Rev 2013;27:44-9.  Back to cited text no. 6
    
7.
Wiersum-Osselton JC, Marijt-van der Kreek T, de Kort WL. Donor vigilance: What are we doing about it? Biologicals 2012;40:176-9.  Back to cited text no. 7
    
8.
Kumari S. Drugs and Cosmetics Act 1940. 16th ed. Lucknow: Eastern Book Company; 2003. p. 279-303.  Back to cited text no. 8
    
9.
Amrein K, Valentin A, Lanzer G, Drexler C. Adverse events and safety issues in blood donation – A comprehensive review. Blood Rev 2012;26:33-42.  Back to cited text no. 9
    
10.
Ditto B, France CR. Vasovagal symptoms mediate the relationship between predonation anxiety and subsequent blood donation in female volunteers. Transfusion 2006;46:1006-10.  Back to cited text no. 10
    
11.
Rohra DK, Juriasinghani V, Rai K, Azam SI. Prevalence of immediate vasovagal reaction in blood donors visiting two blood banks of Karachi. Transfus Med 2010;20:129-33.  Back to cited text no. 11
    
12.
Takanashi M, Odajima T, Aota S, Sudoh M, Yamaga Y, Ono Y, et al. Risk factor analysis of vasovagal reaction from blood donation. Transfus Apher Sci 2012;47:319-25.  Back to cited text no. 12
    
13.
Newman BH. Vasovagal reaction rates and body weight: Findings in high- and low-risk populations. Transfusion 2003;43:1084-8.  Back to cited text no. 13
    
14.
Newman BH, Satz SL, Janowicz NM, Siegfried BA. Donor reactions in high-school donors: The effects of sex, weight, and collection volume. Transfusion 2006;46:284-8.  Back to cited text no. 14
    
15.
Gonçalez TT, Sabino EC, Schlumpf KS, Wright DJ, Leao S, Sampaio D, et al. Vasovagal reactions in whole blood donors at three REDS-II blood centers in Brazil. Transfusion 2012;52:1070-8.  Back to cited text no. 15
    
16.
Meade MA, France CR, Peterson LM. Predicting vasovagal reactions in volunteer blood donors. J Psychosom Res 1996;40:495-501.  Back to cited text no. 16
    
17.
Deacon B, Abramowitz J. Fear of needles and vasovagal reactions among phlebotomy patients. J Anxiety Disord 2006;20:946-60.  Back to cited text no. 17
    
18.
France CR, France JL, Roussos M, Ditto B. Mild reactions to blood donation predict a decreased likelihood of donor return. Transfus Apher Sci 2004;30:17-22.  Back to cited text no. 18
    
19.
Eder AF. Improving safety for young blood donors. Transfus Med Rev 2012;26:14-26.  Back to cited text no. 19
    
20.
Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC, et al. Blood donors and blood collection: Delayed adverse reactions to blood donation. Transfusion 2010;50:556-65.  Back to cited text no. 20
    
21.
Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion 2007;47:1524-33.  Back to cited text no. 21
    
22.
Newman BH, Pichette S, Pichette D, Dzaka E. Adverse effects in blood donors after whole-blood donation: A study of 1000 blood donors interviewed 3 weeks after whole-blood donation. Transfusion 2003;43:598-603.  Back to cited text no. 22
    
23.
Wiltbank TB, Giordano GF, Kamel H, Tomasulo P, Custer B. Faint and prefaint reactions in whole-blood donors: An analysis of predonation measurements and their predictive value. Transfusion 2008;48:1799-808.  Back to cited text no. 23
    
24.
Tondon R, Pandey P, Chaudhary R. Vasovagal reactions in 'at risk' donors: A univariate analysis of effect of age and weight on the grade of donor reactions. Transfus Apher Sci 2008;39:95-9.  Back to cited text no. 24
    
25.
Crocco A, D'Elia D. Adverse reactions during voluntary donation of blood and/or blood components. A statistical-epidemiological study. Blood Transfus 2007;5:143-52.  Back to cited text no. 25
    
26.
Agnihotri N, Marwaha N, Sharma RR. Analysis of adverse events and predisposing factors in voluntary and replacement whole blood donors: A study from North India. Asian J Transfus Sci 2012;6:155-60.  Back to cited text no. 26
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27.
Rios JA, Fang J, Tu Y, Wright DJ, Spencer B, Hillyer CD, et al. The potential impact of selective donor deferrals based on estimated blood volume on vasovagal reactions and donor deferral rates. Transfusion 2010;50:1265-75.  Back to cited text no. 27
    
28.
Crocco I, Franchini M, Garozzo G, Gandini AR, Gandini G, Bonomo P, et al. Adverse reactions in blood and apheresis donors: Experience from two Italian transfusion centres. Blood Transfus 2009;7:35-8.  Back to cited text no. 28
    


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