Adverse reactions in allogeneic blood donors: a tertiary care experience from a developing country.
Generally, blood donors do not experience adverse symptoms and tolerate the donation process very well, but adverse reactions of variable severity occasionally occur during or at the end of the blood collection. (3) Usually, these are minor symptoms related to the donation process. However, rarely, serious adverse symptoms may occur. These symptoms range from a mild vasovagal reaction (VVR), nausea, vomiting, and hyperventilation to hematoma, incontinence, nerve injury, arterial prick, and may culminate in delayed syncope, cardiac arrest, and seizures.
Adverse reactions have been observed in various ethnic backgrounds in 0.6-36% of cases. (4,5) From South Asia, data about adverse donor reactions is available from India and Bangladesh, but there is little data available from Pakistan. To the best of our knowledge, the single study reported looked merely for adverse VVR in healthy blood donors. (6)
The aim of our study was to assess the frequency of these adverse reactions at a tertiary care hospital in Karachi, and also to determine the entire spectrum of different adverse events. We also wanted to determine any association with age, gender, weight, race, and educational status. Thus, our study sought to identify a vulnerable donors group who are at risk of developing various adverse reactions.
This prospective study was conducted over three years, between January 2011 to December 2013. We used the non-probability, feasibility-sampling method and recruited a total of 41,759 allogeneic blood donors. The study was approved by the ethical and research committee of Liaquat National Hospital, Karachi, Pakistan.
Demographic data obtained via a structural questionnaire included the donor's name, age, gender, contact number, donor type (replacement or voluntary), linguistic background, and educational status. All donors were selected according to preestablished inclusion criteria considering age ([greater than or equal to] 18 years), body weight (> 50 kg), hemoglobin levels ([greater than or equal to] 12.5 g/dl), hematocrit levels (HCT) [greater than or equal to] 38%, pulse (50-100 beats/min), and blood pressure (120/80 mmHg). All subjects were asked about their medical and donation history. Donors with a history of jaundice, intravenous drug abuse, non-marital sexual contact, tattoos, and recent blood transfusion or surgery were deferred and excluded from the study. All donors were interviewed and provided written informed consent.
Approximately 500 ml of whole blood was drawn by trained phlebotomists. All donors were observed for any possible adverse events during donation and were detained subsequently for 20 minutes after blood donation. All donors were asked to report back in the case of any delayed adverse events within 24 hours.
Donors were divided into groups based on their age (< 30 and [greater than or equal to] 30 years), gender, linguistic background (Urdu or non-Urdu speaking), weight (< 70, 71-90 and > 90 kg), and education (undergraduate, graduate or postgraduate). NonUrdu speaking languages included Sindhi, Pashto, Punjabi, Balochi, and Hindko.
The frequencies of different adverse reactions in blood donors were calculated. Association between blood donor adverse reactions and age, race, education, and weight was calculated using the chi-square test. A p-value < 0.050 was considered significant. The data was analyzed using SPSS Statistics (SPSS Inc., Chicago, US) version 21.
A total of 41,759 blood donors were enrolled over a period of three years. Of these, 41,511 (99.5%) were replacement donors and 248 (0.5%) were voluntary donors. Almost all donors (41,645; 99.8%) were male. One-hundred and fourteen (0.2%) were female. The mean age was 26.0 [+ or -] 6.8 years and their mean weight was 66.5 [+ or -] 9.4 kg. Of the total number of donors, 537 developed adverse reactions; of these, 429 (79.9%) developed VVR. Donors with VVR showed various signs and symptoms as shown in Table 1. The overall frequency of adverse donor reactions was 1.3% with an estimated incidence of one in every 78 blood donations.
The second most common adverse reaction was nausea in 133 (24.8%) donors followed by fainting (n = 63; 11.8%). Thirty-five (6.5%) donors developed hyperventilation, nine (1.7%) developed delayed syncope, and nine (1.7%) developed hematoma. Arterial prick, nerve injury, cardiac arrest, incontinence, and seizures were not recorded.
An association was seen with age, weight, linguistic background, and educational status. A significant positive association was found between age and VVR (p = 0.000). VVR were seen predominantly in the < 30 years age group. A significant association between age and nausea (p = 0.003) and hyperventilation (p = 0.000) was also seen [Table 2].
There was a significant positive association between VVR and weight (p = 0.004). Donors weighing less than 70 kg were positively associated with VVR (p = 0.004). Nausea (p = 0.017) was also significantly associated with weight. There was a positive correlation between nausea (p = 0.031) and delayed syncope (p = 0.011). Fainting (p = 0.000) and hematoma (p = 0.001) were seen more commonly in donors educated to an undergraduate level.
Blood banks have a dual responsibility: to meet the blood supply for the community and to ensure maximum blood donors safety. The donor's physical experiences have a noticeable impact on donor return, and adverse incidents dictate the donor return rate. (7) Our study revealed adverse donor reactions in 1.3% of healthy Pakistani allogeneic donors. This is the first comprehensive report from Pakistan; a prior study addressed only VVR in replacement donors. (6)
Our results are in concurrence with an Indian study that reported adverse events in 2.5% of healthy blood donors. (8) Another local study from Bangalore, India revealed a prevalence of 2.04%. (9) A relatively high prevalence of 4.9% was reported in a study from Bangladesh that assessed randomly selected whole blood donors. (10)
Compared to data from developed countries, our results are more or less analogous. An Italian study found an overall prevalence 1.2%. (11) A large study from Japan on 98,389 donors recorded a 2.8% positivity rate of adverse reactions. (12) However, a relatively low frequency of 0.63% adverse reactions was determined in a German study, conducted in elderly (66-71 years) voluntary blood donors. (4) This difference is accredited to difference in the age groups of our studies, and the blood donor type (i.e., voluntary donations versus replacement donors) as in our study included virtually all replacement donors. Regular voluntary donors are likely to have less adverse donor reaction.
VVR were the most common adverse reaction occurring in 67-95% of all donation-related reactions and in 1-5% of blood donors. (13) Donation-related VVR is a multifactorial response primarily determined by young age, low weight, female gender, and first-time donor status. (14-16)
Rohra et al, (6) conducted a study in two blood banks in Karachi, Pakistan, and reported a higher prevalence (8.2%) of VVR in 674 exchange blood donors. This difference perhaps could be explained by the majority of donors being aged < 30 years. The sample size was relatively small in their study where as our cohort was larger and is more likely to reflect the actual prevalence in our population.
However, earlier studies from India reported VVR prevalences of 63.5% and 70.0%, which are comparable to our findings of 79.9%.8'17 Age and weight might predict the VVR in blood donors, based on significant associations observed. Previous studies reported a significantly low frequency of VVR in those aged [greater than or equal to] 36 years old. (8) The highest prevalence was seen in the < 30 age group in our study. A study from France postulated that vasovagal reactors exhibited decreased baroreceptor sensitivity in healthy younger donors when they are physically or psychologically strained. (18) With escalating age, the body becomes steadier hemodynamically.
An adverse event was frequently seen in donors who weighed less than 70 kg. Previous studies support our findings. Donors who experienced adverse reactions had a lower mean weight compared to donors without adverse events. (19) Newman also showed that the VVR reaction rate was inversely proportional to the donors weight. (20) A cumulative report from three large US blood centers also revealed that low weight donors had high donation reaction (VVR) rates compared to other donors. (14)
We could not determine any association of gender with adverse reactions because virtually all blood donors were male. Female blood donors constituted 30% of blood donations reported from Italy. (21) However, the situation in Pakistan is even more alarming, where the prevalence was < 1% as reported in prior studies. (6,22) The reasons for the lack of blood donation include insufficient knowledge, lack of education, misconceptions, and false perceptions about blood donation. This is a limitation of our study that hinders the generalization of the results.
However, an Urdu-speaking linguistic background and undergraduate educational status were determined as significantly strong predictors of delayed syncope and fainting, respectively, in our study. In the literature, we did not find other studies that mentioned linguistic background or educational status as a risk factor associated with adverse events. Further studies are needed to validate this finding.
In our cohort, the second and third most common types of adverse events were nausea and fainting. In one European study, fainting was reported as an adverse event in 20.5% of blood donors. (23) The authors of the study concluded that the stressing experience of phlebotomy was the reason for the higher frequency of reactions. There are plausible explanations for this high prevalence compared to our study: the divergence in donor's demographics, perceptions, awareness, and understanding.
Needle injuries can damage vasculature, may result in bruises, hematoma, arterial puncture, arteriovenous fistula, or pseudoaneurysm. Needle injuries were encountered minimally (2%), which was in agreement with a prior study from Bangladesh. (10) However, Newman et al, (24) had disclosed very high frequency of bruises in 15.1% of donors while Agnihotri et al, (8) determined hematoma as an adverse event in 35% of all reactions. Underlying etiology seems to be the faulty technique, untrained phlebotomists and failure to select an appropriate vein. (8) Needle-associated nerve injuries occur in one of every 6300 donations. (24) Nerve injury was not observed in our donors. Additionally, serious fatal adverse reactions such as arterial prick, cardiac arrest, and seizures were not seen.
The prevalence of adverse donor reactions in our study was not high. However, to further minimize these adverse events and sustain the donor pool, we would suggest a number of strategies. These include lessening the donor-to-phlebotomist ratio, more pre-donation counseling, not allowing donors who have fasted before donating to donate, giving more individual concentration to each donor, keeping donors supine for longer, offering fluids before starting phlebotomy, and training blood donors about applying muscle tension exercises. (25)
The prevalence of adverse reactions in allogeneic blood donors in the Pakistani population appears low. VVR is the predominant adverse event. Donation-related adverse reaction is a multifactorial process principally determined by young age, low weight, ethnic background, and undergraduate educational status. Our study strengthens the fact that donation process is a safe maneuver, which could be made further event-free by designing protective practices in the identified predisposed groups.
Received: 28 May 2015
Accepted: 19 October 2015
The authors declared no conflicts of interest. No funding was received for this study.
The authors are grateful to the donors who have participated in this study. We thank the staff of the Blood Bank particularly Mr. Asif Hammed for his support.
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Sadia Sultan  *, Mohammad Amjad Baig , Syed Mohammed Irfan , Syed Ijlal Ahmed  and Syeda Faiza Hasan 
 Department of Hematology and Blood Bank, Liaquat National Hospital and Medical College, Karachi, Pakistan  Liaquat National Medical College, Karachi, Pakistan
* Corresponding author: [mail]firstname.lastname@example.org
Table 1: Distribution of adverse donor reactions (n = 537). Adverse Number of Percentage reactions positive adverse of positive reactions reactions Vasovagal reaction 429 79.9 Weakness 429 79.9 Sweating 404 75.2 Low pulse 393 73.2 Pallor 330 61.5 Dizziness 225 41.9 Nausea 133 24.8 Fainting 63 11.8 Hyperventilation 35 6.5 Delayed syncope 9 1.7 Hematoma 9 1.7 Table 2: Correlation of adverse reactions with age, weight, education, language, and gender. Parameters Vasovagal Fainting reaction n = 429 p-value n = 63 p-value Age (years) < 30 349 0.000 45 0.340 [greater than or 80 18 equal to] 30 Weight (kg) < 70 322 0.004 45 0.190 70-90 98 18 > 90 9 0 Education Undergraduate 170 0.101 45 0.000 Graduate 250 18 Postgraduate 9 0 Language Urdu 268 0.410 0.001 Non-Urdu 161 36 Gender Male 429 -- 63 -- Female 0 0 Parameters Nausea Hyperventilation n = 133 p-value n = 35 p-value Age (years) < 30 89 0.003 17 0.000 [greater than or 44 18 equal to] 30 Weight (kg) < 70 107 0.017 17 0.000 70-90 26 9 > 90 0 9 Education Undergraduate 62 0.021 17 0.351 Graduate 71 18 Postgraduate 0 0 Language Urdu 71 0.031 18 0.210 Non-Urdu 62 17 Gender Male 133 -- 35 -- Female 0 0 Parameters Delayed Hematoma syncope n = 9 p-value n = 9 p-value Age (years) < 30 9 0.121 0 0.000 [greater than or 0 9 equal to] 30 Weight (kg) < 70 9 0.190 9 0.191 70-90 0 0 > 90 0 0 Education Undergraduate 0 0.040 9 0.001 Graduate 9 0 Postgraduate 0 0 Language Urdu 9 0.011 0 0.000 Non-Urdu 0 9 Gender Male 9 -- 9 -- Female 0 0
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|Title Annotation:||ORIGINAL ARTICLE|
|Author:||Sultan, Sadia; Baig, Mohammad Amjad; Irfan, Syed Mohammed; Ahmed, Syed Ijlal; Hasan, Syeda Faiza|
|Publication:||Oman Medical Journal|
|Article Type:||Clinical report|
|Date:||Mar 1, 2016|
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