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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 6  |  Issue : 1  |  Page : 15-21

Hemovigilance: An analysis of adverse effects of blood donation among blood donors in a tertiary-care center


Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India

Date of Submission07-Dec-2020
Date of Decision15-Jan-2021
Date of Acceptance06-Apr-2021
Date of Web Publication29-May-2021

Correspondence Address:
Debasish Gupta
Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/GJTM.GJTM_104_20

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  Abstract 


Background and Objectives: Hemovigilance is defined as a set of surveillance procedures covering the whole transfusion chain that is intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products and to prevent future occurrence and recurrence. The primary goal of the study was to reduce the incidence of adverse events among blood donors and to make blood donation a pleasant experience. Prevention of adverse reactions at the time of blood donation is an important aspect of blood donor motivation and blood donor retention for future blood donations. Methods: This is a one and half year's prospective study which was conducted by the department of Transfusion Medicine. The study assessed untoward blood donor reactions, as a measure to further maximize the elimination of untoward reactions encountered during or after blood donation to secure a healthy donation-transfusion chain. We analysed the causative factors that can lead to complications in blood donors at different phases of blood donation like pre-donation, during donation and post donation phases. Results: Out of 8180 whole blood collections, 252 blood donor complications were observed during the study period. Out of this, 8.73% (n=22) adverse reactions were observed during donation at blood centre, while 91.27% (n=230) reactions occurred in blood donation camps. Among the camp donations, 61.30% (n=141) were at outdoor camps and 38.70% (n=89) were inside Blood Mobile. We had 83.23% (n=6808) of male blood donors and 16.77% (n=1372) of female donors. Out of the 66 females who developed complications, majority were belonging to the age group of 18-25 years. We had 37.90% (n=3100) first time donors and 62.10% (n=5080) repeat donors. Among the repeat donors, 34.59% (n=1757) were regular repeat donors and 65.41% (n=3323) were irregular repeat donors. Out of 130 first time donors who developed complications, 91.5% (n=119) were systemic reactions. 57.1% (n=12) of regular repeat donors and 80.2% (n=81) of irregular repeat donors developed systemic complications. Conclusion: Hemovigilance reporting has reinforced our blood donor safety as well as transfusion safety. Regular reporting of the adverse donor complications helped us to improve proper documentation of all aspects of a complete blood donation sequence not only by the medical officers but also by the blood centre staff members.

Keywords: Blood donation, blood donor, donor reaction, hemovigilance


How to cite this article:
Mani A, Gupta D. Hemovigilance: An analysis of adverse effects of blood donation among blood donors in a tertiary-care center. Glob J Transfus Med 2021;6:15-21

How to cite this URL:
Mani A, Gupta D. Hemovigilance: An analysis of adverse effects of blood donation among blood donors in a tertiary-care center. Glob J Transfus Med [serial online] 2021 [cited 2021 Dec 7];6:15-21. Available from: https://www.gjtmonline.com/text.asp?2021/6/1/15/317116




  Introduction Top


Hemovigilance is an important aspect of blood safety which aims at identification, monitoring, and prevention of adverse reactions, incidents, and adverse events related to blood donation and transfusion for both blood donors and patients.[1] Proper analysis of donor complications and transfusion reactions, incidents and events are essential to identify the contributing factors. Hemovigilance is an important part of the quality system for both blood collection and blood transfusion. It implies the various methods for the identification of errors, adverse events, and reactions including investigation systems, traceability systems, notification systems, and audits of practice.

The donor hemovigilance should include the systematic reporting of unexpected adverse events and complications in whole blood and blood component donors. These events may be adverse reactions or complications resulting from donor selection, donation, and management of donors, which may directly harm the donor or influence the quality of the product, thereby putting the recipient at risk. Blood centers should continuously try improving the practices that are followed to create a pleasant donation experience for all donors. To accomplish such a target, there should be an effective and comprehensive program to monitor donor complications as the pillar stone of a blood donor safety program.


  Aims and Objectives Top


We as a tertiary care center aimed to study the entire donor-related adverse reactions. The donor vigilance includes any adverse reactions in the blood donor from the predonation phase to postdonation phase. Donor vigilance is done to improve the donor comfort and safety so that they get motivated to become a regular nonremunerated voluntary blood donor and will ensure donor retention. Here, we investigated the various donor adverse reactions and the overall measures that can be taken to prevent the occurrence of further adverse reactions in future. This helped us to promote safe blood practices right from the vein of the blood donor to the vein of the transfusion recipient.


  Materials and Methods Top


This is a 1 and ½ year's prospective study which was conducted by the department of transfusion medicine. The department has been designated as a Regional Blood Transfusion Center by the Government of India. As per the directives of the National Blood Policy, collection of blood from replacement donors has been totally phased out by voluntary nonremunerated blood donors from October 1, 2016, by our center.[2]

A regular voluntary nonremunerated blood donor is a donor who has donated at least three times, the last donation being within the previous year, and continues to donate regularly at least once per year.[3] Voluntary blood donors over a period of 1 year are included in the study. Blood donors attending our outdoor blood donation camps and walk-in donors in blood center are being provided with a uniformly structured donor questionnaire and consent form is approved by the Government of India in the prescribed format. Every eligible donor was monitored for any adverse reactions encountered during the entire phase of donation –pre, during, and post donation.[4] Donor adverse reactions include both acute and delayed reactions. Again these reactions are subclassified into local and systemic reactions according to the ISBT 2014 revised criteria.[5]

For the study purpose, we have introduced a donor reaction reporting form (DRRF). This form was filled up by the medical officers who were in charge of the camp or the blood center. The DRRF includes the demographic details of the donor, previous blood donation history, medical history, and signs and symptoms of reactions including recording of vitals such as blood pressure, pulse, and the possible causative factors for such different adverse reactions. This guided us to diagnose the type of donor reaction. Subsequently, medical officer would fill the above-mentioned DRRF. After recovery, the donor would be informed about the study undertaken and he/she would be handed over the participant information sheet. After a thorough understanding of the details provided, the donor had to sign the informed consent form to make him/her a part of the study.

We analyzed the donor reactions with different parameters such as age, gender, body weight, estimated blood volume (EBV), type of donor, phase of donation, previous donation history, venue of donation, and seasonal variations. The EBV of the blood donors who developed complications was calculated using Modified Gilcher's Rule of Five.[6]

Ethics

The study was cleared by our Institutional Ethics Committee SCT/IEC/1224/JUNE-2018.

Exclusion criteria

The following exclusion criteria were adopted:

  1. All type of apheresis donors
  2. Autologous blood donors
  3. Noneligible blood donors
  4. Platelet-rich plasma donors for regenerative medicine
  5. Donors not reporting back if the reaction occurs after the donor has left the blood donation premise.


Statistical analysis

Numerical data were expressed as mean ± standard deviation and categorical data as frequencies and percentage. Association between categorical variables was analyzed using the Chi-square test. Continuous variables were compared between two group using Student's t-test and with more than two groups with ANOVA. All statistical tests were two sided. P < 0.05 was considered statistically significant. Data analysis was performed using R software (R version 3.6.2 [December 12, 2019)) and SPSS (version 16.0).


  Results Top


Out of 8180 whole blood collections, 252 blood donor complications were observed. Out of this, 8.73% (n = 22) adverse reactions were observed during donation at blood center, while 91.27% (n = 230) reactions occurred in blood donation camps. Among the camp donations, 61.30% (n = 141) were at outdoor camps and 38.70% (n = 89) were inside bloodmobile. No statistical significance was observed between the site of blood donation and different types of donor complications.

Among the total collection, 83.23% (n = 6808) were male and 16.77% (n = 1372) were female. Out of the 66 females who developed complications, 51.5% (n = 34) and 22.7% (n = 15) were belonging to 18–20 years and 21–25 years, respectively. Out of 186 males who developed complications, 23.7% (n = 44) and 36.6% (n = 68) were belonging to 18–20 years and 21–25 years, respectively. Hence, a statistically significant association was observed between younger age group and female gender in the development of donor complications (P < 0.001) [[Table 1] describes blood donor details].
Table 1: Blood donor details

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Out of 66 females who developed complications, 16.7% (n = 11) and 48.5% (n = 32) had weight of 45–50 kg and 51–60 kg, respectively. Out of 186 males who developed complications, only 2.7% (n = 5) and 21% (n = 39) had weight of 45–50 kg and 51–60 kg, respectively. A statistically significant association was obtained between body weight <60 kg and female gender in the development of blood donor complications (P < 0.001). No statistically significant association was observed between the gender of blood donors and various types of donor complications [[Table 2]: various types of blood donor complications].
Table 2: Distribution of various blood donor complications

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Out of 212 donors who developed systemic complications, 92.3% (n = 72), 84.3% (n = 70), and 80.4% (n = 41) were in the age group of 18–20 years, 21–25 years, and 26–30 years, respectively. Blood donors <25 years of age were found to have more systemic reactions. There was a statistical significance between younger age of blood donation and the development of systemic complications (P < 0.001).

We had 37.90% (n = 3100) first-time donors and 62.10% (n = 5080) repeat donors. Among the repeat donors, 34.59% (n = 1757) were regular repeat donors and 65.41% (n = 3323) were irregular repeat donors. Out of 130 first-time donors who developed complications, 91.5% (n = 119) were systemic reactions. About 57.1% (n = 12) of regular repeat donors and 80.2% (n = 81) of irregular repeat donors developed systemic complications. First-time and irregular repeat donors were found to have more systemic complications and statistically significant association was observed between the development of systemic reaction and type of voluntary blood donor (P < 0.001).

Majority of blood donors who developed complications were belonging to <30 years of age with an EBV between 4010.9 ml and 4858.7 ml. A statistical significance was observed between <30 years of age and EBV in the development of donor complications (P < 0.001). All females who developed reactions had a mean EBV ranging between 3748.5 ± 630.5 ml and 186 males had 4857.4 ± 914.5 ml. A statistical significance was observed between the gender of blood donors and EBV in the development of donor complications (P < 0.001). No statistical significance was observed neither between body weight and the development of systemic reactions nor with EBV and systemic reactions.

The mean time of blood collection was 5.37 ± 1.26 min for 210 systemic complications and 4.75 ± 1.65 min for 35 local complications. Statistical significance was observed between systemic reactions and time taken for blood collection (P = <0.001). No statistical significance was observed between the volume of blood collected and different types of donor complications. We could not obtain any statistical significance between the time since last meal and hours of sleep in the causation of various types of donor complications.

Maximum number of donor reactions were observed in the month of May, followed by November, September, and January. About 11.5% (n = 29) of the blood donor complications were observed in the month of May and 11.1% (n = 28) in November. Nearly 10.7% (n = 27) complications were observed in the month of September and 10.3% (n = 26) in January. No statistical significance was observed between seasonal variations and different types of donor complications.


  Discussion Top


The most common age group of voluntary blood donors in our study who developed donor complications was 18–25 years. The mean age of the study population was 24.88 ± 6.581 years. We could observe a significant association between younger age of blood donation and female gender in the increased occurrence of donor complications in our study. A similar observation was stated in a study by Murphy and Mcsweeney[7] and Goldman et al.[8] Younger age of donation and female donors are both significant predictors of vasovagal reactions (VVR).[9]

About 73.4% of the donor complications were VVRs that were constituted by pallor, dizziness, and sweating and the rest of the VVRs were accompanied by loss of consciousness (LOC) and/or seizures and some of the VVRs occurred along with local reactions. We had 5.2% of the VVRs to be accompanied with LOC without injury and 1.2% were LOC with seizures but without injury. Nearly 0.8% were delayed VVRs and 1.2% were VVRs accompanied with local complications (arterial puncture and hematoma).

In the present study, the incidence of donor complications was 3.8% out of the total collection and 0.02% (n = 2) were predonation reactions out of total registered donors. A convulsive VVR rate of 1.2% which is similar to our study has been mentioned in a study by Crocco and D'Elia.[10] We have got LOC without injury reaction rate of 5.2% likewise reported by Resident et al.[11] A case of severe delayed VVR with injury was reported by Rajendran et al.[12]

Ten percent of the donors developed hematoma as an isolated complication without any other accompanying systemic or local reactions. This was comparable with a hematoma rate of 9%–16% reported in the study by Newman et al.[13] The accidental arterial puncture rate was 0.4% in our 1-year study period. Twelve such cases in a period of 2 years were reported by Newman et al.[14] Arterial puncture has also been reported in a study by Agnihotri et al.[15]

It is observed that female donors with low body weight have encountered more systemic reactions than male donors and this is comparable with a study done by Newman[16] They have found out low body weight was an independent risk factor for the development of VVR and their study had a good number of female participants as well. Same observations about low body weight and increased risk of systemic donor complications are mentioned in a study done by Goldman et al.[8] Weight as such was not the actual risk factor, but the volume of blood drawn from the donor may predict the reaction rate as per Tondon et al.[9]

A statistically significant association has been observed between the first-time blood donors and increased number of systemic donor complications than in repeat donors or regular donors. First-time donors were found to have more incidence of VVRs in studies by Wiersum-Osselton et al.[17] and Eder et al.[18]

We could obtain a statistically significant association between the age and EBV of donors in the occurrence of blood donor complications as the donors <25 years of age with an EBV of <4.5 L were found to develop more donor complications. Blood donors <25 years of age with an EBV <3.5 L were found to develop more systemic reactions.[19] The importance of low blood volume and the consequent occurrence of systemic donor reactions has been emphasized in studies by Philip et al.[20] and Tomasulo et al.[21]

Our study has also observed a statistically significant association between females with low EBV in the occurrence of donor complications. Even though our study could not demonstrate any statistical significance between the occurrence of systemic donor complications and EBV, other studies have stated low EBV to be a major risk factor for VVRs.[22]

Donors with low blood volume, first-time donors, with low weight, and female donors had higher absolute donation VVR rates than other donors.[20],[23] Predonation hydration has got a beneficial effect on the reduction of systemic complications.[24],[25],[26],[27]

Even though our study could not demonstrate any statistical significance between seasonal variations and increased incidence of blood donor systemic complications, more number of systemic reactions were observed during the months of May, November, September, and January. More donor reactions in the month of May may be due to immense heat of summer season and inadequate hydration status of blood donors. In Kerala, September will be rainy season and December and January will be winter season; however, a greater number of systemic complications encountered in these months were due to the poor hydration status of the blood donors during cold season. This assumption was further strengthened by the increased incidence of local complications in winter months due to poor venous access. We could effectively reduce both these complications after implementing proper predonation hydration of the blood donors.

We could observe that both systemic and local donor complications were more during rainy and winter months, and henceforth, hydration status of the donors plays a pivotal role in the decreased incidence of blood donor complications. In Japan, the reaction rates were more during spring season and they have explained this to be because of the fact that spring is the season of climatic change and social stress and thereby more attributing to psychological factors.[28] Another study in Wisconsin has shown that their peak incidences of reactions were in the months of April, July, and November with relatively lower rates in January and September done by Callahan et al.[29]

There was an increased incidence of donor reactions in bloodmobiles during summer season and decreased incidence during winter months.[30] However, we could not find any statistical significance between the venue of blood donation and the increased incidence of blood donor complications.

The systemic adverse reaction rates were more among young first-time donors, female donors, and donors with low EBV. To attain a solution to reduce the reaction rates among those donors, we introduced predonation oral hydration with water for all young first-time donors with low EBV. We made our donor selection procedure much more stringent in such a way that all donors who are at risk of developing complications are well hydrated prior to the initiation of blood donation and the donors will be distracted by means of continuous verbal communication during the process of blood donation. We initiated training strategies to improve the phlebotomy skills of our phlebotomists to reduce local complications.

Another safety measure we have adopted is a two to one care practice where two donors will be taken care by one staff member throughout the donation process and to accomplish this in the campsite donation, we have limited the donor couch numbers to be 4 to a maximum number of 5 at a time. Predonation hydration will help to reduce the incidence of systemic complications as well local complications like hematoma by establishing a better peripheral venous access. In addition to these, those blood donation campsites were we anticipate more donor complications like as in women's colleges or in institutions where more young first-time donors are expected, before the commencement of blood donation; medical officer in charge of the camp will address the donors and will make them comfortable by making them aware regarding the benefits along with Do's and Dont's of blood donation.

Instead of excluding the donors who are at risk of developing adverse reactions from blood donation, we have included these donors in blood donation after ensuring the safety measures. Donor deferral is a real demotivating factor which can badly affect donor retention and even donor recruitment. Donor retention is the backbone of voluntary blood donation through which we can sustain more mobilizations of voluntary blood donors to phase out replacement donation gradually. A pleasant donation experience can promote altruism among blood donors, thereby motivating themselves to come forward for future donations to become a regular voluntary blood donor.


  Conclusion Top


Hemovigilance reporting has helped us to improve both blood donor safety and transfusion safety. Regular reporting of the adverse donor reactions led to the increased documentation on all the allied complications not only by the medical officers but also by the staff members. As far as the blood donation and associated complications are concerned, the inference obtained regarding the various reasons that lead to adverse reactions helped us to improve our donor care from the predonation phase itself. Our study has shown more incidences of adverse reactions among young donors, female gender, donors with low EBV, and first-time donors. Instead of excluding such donor populations from blood donation, we have included them in our donor pool by making them more comfortable by creating more awareness on blood donation by means of pleasant interaction with the donor and by prehydration of donors who are at risk of developing systemic donor complications. A proper predonation and postdonation instruction to restrict lifting of heavyweight with the donated arm and incorporation of well-trained phlebotomy staff has drastically reduced the incidence of local complications like hematoma as well.

Acknowledgments

We thank the Director, Sree Chitra Tirunal Institute for Medical Sciences and Technology and Department of Transfusion Medicine, for permitting us to perform the study. We also acknowledge all staff members of the Department of Transfusion Medicine, SCTIMST, who helped to successfully complete the study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Agnihotri N, Chaturvedi YM, Agnihotri A. Arterial phlebotomy in a whole blood donor and consequent adverse events. Indian J Hematol Blood Transfus 2018;34:562-3.  Back to cited text no. 15
    
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