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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 4  |  Issue : 1  |  Page : 28-32

On-site and off-site adverse donor reactions in voluntary whole blood donors: A study from a tertiary care oncology center


Department of Transfusion Medicine, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India

Date of Web Publication22-Apr-2019

Correspondence Address:
Dr. Priti D Desai
Department of Transfusion Medicine, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/GJTM.GJTM_4_19

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  Abstract 


Aim: The aim of this study was to analyze the frequency of on-site and off-site adverse donor reactions and its correlation with contributory factors if any. Materials and Methods: A prospective observational study was conducted from October 2016 to November 2016. A total of 1000 voluntary whole blood (WB) donors who consented to participate in the study were contacted telephonically the next day of donation. Donors were asked a structured questionnaire and information was documented. Results: Of the 1000 voluntary WB donors, 948 responded to the phone calls. Of these 948, 79 (8.33%) donors experienced adverse reactions. Of the 79 donors, 33% (26/79) reactions occurred on-site, whereas 67% (53/79) reactions occurred off-site (P < 0.05). Of the total on-site reactions, 92% (24/26) were vasovagal reactions (VVRs) and 8% (2/26) were hematomas (P < 0.001). Of the total off-site reactions, 47% (23/53) were vasovagal and 53% (30/53) were hematomas. Of the 79 donors, 60% (47/79) experienced VVR and 40% (32/79) experienced hematomas. Of the 32 hematoma reactions, 94% (30/32) were noticed off-site, whereas 6% (2/30) occurred on-site (P < 0.001). Majority of hematomas took more than 7 days to resolve. Conclusion: Maximum reactions occurred off-site, and hence donor follow-up after the donor has left the donation site is important. Postdonation follow-up proves to be an efficient tool to acquire information about adverse donor reactions. The next day telephonic follow-up was helpful as donor recall of the off-site reactions was better, which otherwise would have gone unreported.

Keywords: Adverse reactions, follow-up, off-site, postdonation care


How to cite this article:
Desai PD, Navkudkar AA, Rajadhyaksha SB. On-site and off-site adverse donor reactions in voluntary whole blood donors: A study from a tertiary care oncology center. Glob J Transfus Med 2019;4:28-32

How to cite this URL:
Desai PD, Navkudkar AA, Rajadhyaksha SB. On-site and off-site adverse donor reactions in voluntary whole blood donors: A study from a tertiary care oncology center. Glob J Transfus Med [serial online] 2019 [cited 2019 Aug 20];4:28-32. Available from: http://www.gjtmonline.com/text.asp?2019/4/1/28/256756




  Introduction Top


Blood donation is considered to be a valuable contribution to the society. Whole blood (WB) donation is a regular activity to meet the increasing demands of blood component requirement in any health-care center. Blood donation by healthy volunteers assures the availability of blood components for transfusion, which is a central tenet of modern health care.[1] Safety issues in transfusion medicine have been concentrated on donor and recipient safety. For this reason, stringent blood donor selection criteria are followed by blood transfusion services (BTS). Blood donation experience should be pleasant to retain blood donors for regular blood donation. Removal of blood during donation process is physiologically well tolerated by most of the donors; however, few donors do experience adverse donor reactions. Most of the adverse reactions are managed by simple measures, but a few reactions may take a longer time to recover. An incidence of an adverse donor reaction can have a negative impact on donor return rate. Donors will eventually refrain from donating in future, which would lower the blood supply in donation centers.[2] About 9% of donors who experience adverse reactions at their first donation did not return for the subsequent donation.[3]

On-site reactions (reactions which occur at the donation site) can be addressed at the donation site, but off-site reactions (reactions which occur once the donor has left the donation site) can go unnoticed unless reported by the donor. The study of adverse donor reactions is important because by analyzing this information, corrective measures can be taken to minimize and avoid it. Although the donor-screening criteria are stringent and despite good postdonation care, adverse reactions may occur and vary in severity. This questions the need for evidence-based recommendation for prevention of occurrence of adverse donor reactions. On-site reactions which occur at the donation site are reported, and additional attention can be given during the immediate postdonation period. Often, the off-site reactions are underreported, as they go unnoticed. If these donors are followed up by BTS, the factors predisposing these reactions can be identified, and appropriate postdonation care advice can be given to the donors. These types of studies are important to understand the various factors affecting donor experience and donor satisfaction. Being a tertiary care oncology center, the requirement of safe blood and blood components is ever increasing. To meet these demands, adequate blood inventory has to be maintained through our regular voluntary WB donors to ensure the supply of safe blood and blood components.

Therefore, the purpose of the study was to analyze the on-site and off-site adverse reactions in WB donors and contributing factors if any. In the long run, this will help us in enhancing donor satisfaction and hence donor retention.


  Materials and Methods Top


This was a prospective observational study conducted over a period of 2 months from October 2016 to November 2016. The study was approved by the Institutional Ethics Committee to evaluate adverse reactions in the first 1000 WB donors, who met the eligibility criteria for WB donation during this period. Informed consent was undertaken from each donor who wished to participate in the study. The donors who consented to participate in the study were contacted telephonically the next day to obtain information regarding the off-site reactions. On-site reactions were defined as reactions occurring at donation site, whereas off-site reactions were defined as those which occurred once the donor had left the donation site [Table 1].
Table 1: Total number of on-site and off-site reactions

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Data collection

Variables used for the analysis were gender, donation status, donation site, and type of reactions (on-site or off-site and vasovagal reaction [VVR] or hematoma). Documentation for any adverse donor reactions that occurred at the donation site was done on donor record card as per the standard operating procedure (SOP). Donors were asked a structured self-designed questionnaire and information was documented on it.

Statistical analysis

The overall analysis of the data was descriptive with results presented as percentage for categorical data. Statistical analysis was done using Statistical Package for the Social Sciences Version 22.0 (IBM Corp., NY, USA). Chi-square test in cross-tables was applied to see relationship between different variables. If P ≤ 0.05, it was considered to be statistically significant.


  Results Top


The study sample comprised of 1000 voluntary WB donors who consented to participate in the study. Of the 1000 blood donors, 948 donors responded to the phone call. Overall, 87% (825/948) of the donors were male and 13% (123/948) were female. The mean age of the donors was 31.5 ± 9.1 years (95% confidence interval [CI] of 30.94–32.06) and the mean weight was 74.7 ± 13.2 kg (95% CI of 73.89–75.51). The mean systolic blood pressure (BP) and diastolic BP were 123 ± 11 mmHg and 77 ± 6 mmHg, respectively.

Of the 948 blood donors, 8.33% (79/948) donors experienced adverse reactions. Of the 79 donors with adverse reactions, 33% (26/79) reactions occurred on-site, whereas 67% (53/7) reactions occurred off-site (P < 0.05) [Table 1]. No correlation was observed between age, weight, BP, and adverse donor reactions.

Overall reactions in female donors were more (24% [29/123]), as compared to the male donors (6% [50/825], P < 0.05). Reactions in the first-time female donors were more both in on-site (71%) and off-site (59%), as compared to the repeat female donors (P < 0.001). Donor reactions in outdoor blood donation camps, both on-site and off-site, were higher as compared to in-house donations (P < 0.05).

Of the total on-site reactions, 92% (24/26) were VVRs and 8% (2/26) were hematomas (P < 0.001). Of the total off-site reactions, 47% (23/53) were vasovagal and 53% (30/53) were hematomas.

Of the 79 donors, 60% (47/79) experienced VVR and 40% (32/79) experienced hematoma. VVRs were categorized into mild, moderate, and severe. Of the 47 donors who experienced VVR, majority, i.e., 76% (36/47), were of mild variety. Of the 32 hematoma reactions, 94% (30/32) were noticed off-site, whereas 6% (2/32) occurred on-site (P < 0.001). Majority (53%) of hematomas took more than 7 days to resolve [Table 2].
Table 2: Correlation of on-site and off-site reactions with gender, donation status, place of donation, and type of reaction

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  Discussion Top


Blood donation is a safe process though blood collection sometimes may cause adverse reactions in donors. BTS are concerned about it because moderate-to-severe donor reactions could affect donor return rate and decrease the potential donor pool. Therefore, it is important to identify the adverse donor reactions and the risk factors associated with it and manage them to improve blood donation experience. Adverse donor reactions can be classified as on-site and off-site. Many off-site reactions may go unnoticed unless the donor reports back to BTS. Hence, limited data are available regarding these adverse reactions. Most studies analyzed adverse donor reactions occurring during the blood collection process and did not include postdonation follow-up of the donors.[4],[5],[6],[7],[8],[9],[10] One of the recent Indian studies showed that the postdonation interview increased the detection rate for blood donor adverse reactions to 10.3%.[11] The studies which conducted a postdonation follow-up for delayed adverse reactions increased the adverse donor reaction detection rate. The incidence of adverse reactions in the present study was 8.33% (79/948), whereas different studies showed the incidence of adverse reactions to be 2% to 7%.[1],[10],[12]

Of the 79 adverse donor reactions, VVRs constituted 60% (49/79) and hematomas 40% (32/79). In a study by Agnihotri et al., VVRs constituted 63.5% and hematomas 35% of all on-site reactions.

The present study showed 76%, 18%, and 6% of mild, moderate, and severe VVRs, respectively [Table 3]. Different studies by Agnihotri et al. and Abhishekh et al. also showed mild VVR to be the most frequent adverse reactions.[13] Hematoma was more commonly observed in repeat donors as compared to first-time donors (4% vs. 2%) similar to Tiwari et al.'s study, where the bruise was also observed in regular donors.[11] Most of the hematomas took more than 7 days to resolve. These results were documented, as donors with hematoma are followed up again at a later date to ensure its resolution. This follow-up is according to the institutional SOP. Of the 32 donors who had off-site hematoma, 2 donors experienced off-site VVR as well. Active follow-up of the donors must be done by the BTS to avoid the donor reactions to go unreported. In our study, 67% of off-site adverse reactions could be detected and reported because telephonic calls were made the day after donation. In the present study, the off-site reaction rate was higher than the on-site reactions, and a similar finding was also observed for delayed adverse reactions by Tiwari et al. and Newman (10% and 36%, respectively).[9],[11]
Table 3: Severity of vasovagal reactions

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Importance of postdonation follow-up

Although many blood centers encourage donors to report about the adverse reactions which occur after leaving the donation site, a very few donors report back to the BTS. Hence, it becomes difficult to acquire correct information regarding the off-site donor reactions. Thus, the postdonation next day follow-up proved to be an efficient tool to collect this information correctly and systematically. The information about donor adverse reactions should be utilized by blood center in understanding factors contributing to it and thus providing better donor care. Blood donors have a feeling of being well-treated and well-taken care of that may promote blood donors to continue as repeat donors and will have a positive impact on the national blood supply.

Annual Serious Hazards of Transfusion (SHOT) data and donor hemovigilance

The postdonation interview can be used to acquire information about delayed adverse reactions and also donor feedback. It can also provide an insight into donor experiences and can be used as a valuable tool for donor hemovigilance. Donor hemovigilance is a comprehensive, centralized, and well-structured approach to collect, collate, and analyze the data to continuously improve donor safety. In 2017, the UK blood services collected approximately 1.9 million donations and reported 50 serious adverse events of donation (SAED) in 2017.[14] Serious adverse events are very rare but do occur and can have a significant impact on donor health and donor retention. According to the Serious Hazards of Transfusion (SHOT) annual report 2017, vasovagal events resulting in donor hospitalization or injury and nerve injuries postvenipuncture continue to be the commonly reported SAED.[14] Donors need a clear understanding of what, when, and how to report adverse events. Donor hemovigilance, the systematic monitoring, and surveillance of such adverse events help improve donor and overall transfusion safety.

As per the Haemovigilance Programme of India, donor vigilance, i.e., reporting of adverse reactions associated with blood donation, is included in the National Blood Donor Vigilance Programme, which was launched on June 14, 2015.[15]


  Conclusion Top


Although the process of blood donation is safe, a small proportion of donors might experience delayed reactions which may have serious implications if not managed properly. Postdonation advice must be provided to all donors, which should include the risk of delayed (off-site) reactions and advice on its prevention. Postdonation follow-up proves to be an efficient tool to acquire information about adverse donor reactions. The next day follow-up was helpful as donor recall of the reactions was better, which would otherwise have gone unreported. This can also be used as a valuable tool for donor hemovigilance. This will help in improving donor safety and satisfaction and will have a positive impact on the national blood supply by improving donor return rate.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Eder AF, Dy BA, Kennedy JM, Notari EP, Strupp A, Wissel ME, et al. The American Red Cross donor hemovigilance program: Complications of blood donation reported in 2006. Transfusion 2008;48:1809-19.  Back to cited text no. 1
    
2.
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;31:142-5.  Back to cited text no. 2
    
3.
van Dongen A, Abraham C, Ruiter RA, Veldhuizen IJ. The influence of adverse reactions, subjective distress, and anxiety on retention of first-time blood donors. Transfusion 2013;53:337-43.  Back to cited text no. 3
    
4.
Kasprisin DO, Glynn SH, Taylor F, Miller KA. Moderate and severe reactions in blood donors. Transfusion 1992;32:23-6.  Back to cited text no. 4
    
5.
Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH, Popovsky MA. A case-controlled multicenter study of vasovagal reactions in blood donors: Influence of sex, age, donation status, weight, blood pressure, and pulse. Transfusion 1999;39:316-20.  Back to cited text no. 5
    
6.
Tomasulo PA, Anderson AJ, Paluso MB, Gutschenritter MA, Aster RH. A study of criteria for blood donor deferral. Transfusion 1980;20:511-8.  Back to cited text no. 6
    
7.
Newman BH. Donor reactions and injuries from whole blood donation. Transfus Med Rev 1997;11:64-75.  Back to cited text no. 7
    
8.
Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC, et al. Delayed adverse reactions to blood donation. Transfusion 2010;50:556-65.  Back to cited text no. 8
    
9.
Newman BH. Vasovagal reactions in high school students: Findings relative to race, risk factor synergism, female sex, and non-high school participants. Transfusion 2002;42:1557-60.  Back to cited text no. 9
    
10.
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. 10
    
11.
Tiwari AK, Aggarwal G, Dara RC, Arora D, Srivastava K, Raina V. Post-donation telephonic interview of blood donors providing an insight into delayed adverse reactions:First attempt in India. Transfus Apher Sci 2017;56:141-6.  Back to cited text no. 11
    
12.
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. 12
[PUBMED]  [Full text]  
13.
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. 13
    
14.
Bolton-Maggs P, Poles D. On Behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2017 Annual SHOT Report. 2018. Available from: www.shotuk.org. [Last accessed on 2019 Mar 20].  Back to cited text no. 14
    
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Bisht A, Singh S, Marwaha N. National blood donor vigilance programme: India. Asian J Transfus Sci 2016;10:1-2.  Back to cited text no. 15
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