European Journal of Cardiovascular Medicine

Blood donation can save someones life .Normally blood donation is a safe procedure. But sometimes adverse reactions can occur. Adverse donor reaction is  an event or complication experienced by the donor before, during, or after the blood donation process [2] .An Adverse event  was defined as the symptoms or signs of donor discomfort of sufficient severity such that either the donor called for attention of the staff or they were noticed by the staff. Pain at the time of venepuncture was excluded [3].

Hemovigilance is an important aspect of blood safety which aims at identification, monitoring and prevention of adverse reactions[4] .Hemovigilance program that classifies complications into defined categories with severity ratings (minor/major) for certain types of reaction [5]. This study will focus on frequency of adverse events occurring in blood donation.

Aim and Objective

To estimate the proportion of adverse events occurring due to blood donation in healthy donor, to assess the type of adverse events during blood donation and to look for associated factors with adverse reaction

Record based cross sectional study at Blood centre of Dr.Somervell Memorial CSI Medical College &Hospital, Karakonam in Thiruvananthapuram, Kerala. Donors attending the blood centre during the year2019, 2020, 2021, 2022 and 2023 Donors attending the outreach camps in this period also included.  Persons not eligible for blood donation are excluded.

Donor adverse reactions were monitored pre, during and post donation by the attending medical officer. All the reactions from the camp as well as blood center were entered in a Donor Reaction register. From donor card the details of donor ID, Age, gender, weight of donor, previous donation history, medical history will collect and from donor reaction register  type of reaction, sign and symptoms, vitals recorded at the time of reaction and the management..

Blood donors attending our blood center and the outdoor blood donation camps are being provided with a standard uniformly structured donor questionnaire and consent form by rules implemented by the Drug and Cosmetic Act, Ministry of Health and Family Welfare, Government of India. The data available as donor reactions recorded by our blood centre over a period of past 5 years was analyzed after approval from the Institutional Ethics Committee.

Data analys is

All the data expressed and categorized as frequencies and percentage. Association between categorical variables analyzed using the chi-square test. Data will be entered in excel and analysed using SPSS version 27.All qualitative variables will be expressed in proportion and quantitative variables will be expressed in mean and standard deviation.

The total number of blood donors during the entire study period was 7777 in which 1108(14.2%) voluntary blood donors and 6669 (85.8%) replacement donors. Out of the total donors 7453 (95.8%) were males and 324(4.2%) were females. 25(0.3%) donors had developed adverse donor reaction. Adverse donor reaction was present in 24 male donors and 1 female donor.

The total no. of donors in 2019, 2020, 2021, 2022, 2023 were 1463, 1207, 1343, 1654, 2110 respectively[Fig.1]

Table 1

Among 25 donors who developed adverse reaction 15 were first time donors and 10 were repeat donors. Vasovagal syncope was the most common systemic donor reaction developed in 23 of the total donors. The most common vasovagal symptom was giddiness followed by hypotension, nausea, sweating and palpitation. One donors developed loss of consciousness after donation. One donor developed numbness (local reaction).

An Adverse donor reaction was classified into local and systemic reactions.

Local reactions are problems related to needle injury and are mainly characterized by extravasations of blood & pain. Consisting of Hematoma formation, Difficulty with blood flow, Accidental puncture to the artery, Delayed bleeding, Nerve irritation, Nerve injury and Tendon injury.  Systemic reactions are vasovagal generated by the autonomic nervous system and further stimulated by psychological factors. The reactions are more common in young donors, female donors, and first-time donors.

Our study reinforces that blood donation is a safe procedure which could be made even more event free by analyzing adverse events, identifying the donors at risk of donor reactions and adopting appropriate donor motivational strategies, pre-donation counseling, and care during and after donation, strict adherence to guidelines in donor examination & selection.

The study done by Beulah M and Fathima JL. consisted of 37,007 whole blood donors, with 35347 (95.51%) males and 1660 (4.48%) females. Among 37,007 donors, 316 donors had adverse reactions out of which 287 were males and 29 females. There were 238 first-time donors and 78 repeat donors. The vasovagal Reaction was the most common 307 donors (97.15%) systemic ADR seen. Local reactions were seen in 9 donors (2.84%)[1]

The retrospective study conducted by Sultan S et al Out of 41,759 blood donors, 537 experienced adverse reactions. The incidence was one in every 78 donations. Out of 537 donors, 429 (80%) developed vasovagal reaction (VVR)  (6)

The hospital-based study conducted by Dogra A, Sidhu M, Dogra M and Raina TR. Overall 108 adverse events were reported in relation to 29,524 donations, resulting in overall adverse event rate of 0.365 %. Presyncopal reactions in other words vasovagal reactions of mild intensity, were the most commonly observed adverse reactions and accounted for approximately 58/108 (53.70 %) of all adverse reactions noted.  (7)

A cross sectional study was done by Rajvanshi DR, Kothari DF, Dighe DM, Patel DJ  The prevalence of adverse reactions to blood donation was (315/35027) 0.9%; this occurred more frequently in first time donors compared to repeat blood donors. Presyncopal reactions were the most frequent adverse reaction encountered among the donors 52.38% .(8)

This study concluded that the adverse reactions can be reduced with appropriate donor selection and proper counseling. These actions may reduce the adverse donor reactions or reduce severity of the reactions and encourage the donors for subsequent donation by doing this donor return rate can be improved

1.       Beulah M, Fathima JL.Pattern of Donor Adverse Reactions in Blood Donation in a Tertiary Care Hospital in Bangalore, India [Internet].2023 July ;12(3):PO39-PO41. 

2.       Gonçalez TT, Sabino EC, Schlumpf KS, Wright DJ, Lea S, Sampai D, et al. Vasovagal reactions in whole blood donors at three REDS II blood centers in Brazil. Transfusion. 2012;52(5):1070-78

3.       Agnihotri N, Marwaha N, Sharma RR (2012) Analysis of adverse events and predisposing factors in voluntary and replacement whole blood donors : a study from north India. Asian J Transfussion p:155–160

4.       ISBT. Standard for Surveillance of Complications Related to Blood Donation Introduction to the 2017 revised classification. Work Gr Donor Vigil Int Soc Blood Transfus Work Party Haemovigilance.2014.         p.1-5.

5.       Pathak C, Pujani M, Pahuja S, Jain M (2011) Adverse reactions in whole blood donors: an Indian scenario. Blood Transfusion .p :46–49

6.       Sultan S, Baig MA, Irfan SM, Ahmed SI, Hasan SF. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country. Oman Med J. 2016 Mar;31(2):124-8. doi: 10.5001/omj.2016.24.

7.       Dogra A, Sidhu M, Dogra M, Raina TR. Study of adverse whole blood donor reactions in normal healthy blood donors: experience of tertiary health care centre in jammu region. Indian J Hematol Blood Transfus. 2015 Mar;31(1):142-5. doi: 10.1007/s12288-014-0396-y. Epub 2014 May 8.

8.      Rajvanshi DR, Kothari DF, Dighe DM, Patel DJ. A study of adverse reactions in whole blood donors in vadodara, gujarat. 2019Jun.1 [cited 2024Apr.11];3(5):186-9.