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| ORIGINAL ARTICLE |
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| Year : 2015 | Volume
: 6
| Issue : 4 | Page : 148-153 |
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Prevalence of acute adverse reactions among whole blood donors: A 7 years study
Sonam Kumari
Department of Transfusion Medicine, Gian Sagar Medical College, Patiala, Punjab, India
| Date of Web Publication | 16-Dec-2015 |
Correspondence Address:
Sonam Kumari
H. No. 120, Sector 20 A, Chandigarh - 160 020
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/1658-5127.171989
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 |
| Introduction | |  |
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 | | |
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 | | |
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]. | 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 | | |
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 | | |
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
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]
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