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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 11  |  Issue : 2  |  Page : 20-23

Donor selection and deferral pattern in convalescent plasma donor in plasmapheresis unit of a tertiary care hospital


Department of Pathology, Assam Medical College & Hospital, Dibrugarh, India

Date of Submission23-Jul-2021
Date of Acceptance27-Jul-2021
Date of Web Publication05-Oct-2021

Correspondence Address:
Dr. Mustafizur Rahman
NEC Hostel, Assam Medical College & Hospital, Dibrugarh 786002
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ajoim.ajoim_4_21

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  Abstract 

Context: The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019. The management plan is supportive care with oxygen supplementation and mechanical ventilation. US FDA approved convalescent plasma (CP) for COVID-19 for clinical trials and as an emergency investigational new drug. Although numerous trials are currently investigating the safety and efficacy of CP in COVID-19 patients, there is a paucity of ongoing and published studies evaluating the CP donors’ side. This retrospective study reports the CP donors’ selection and deferrals. Aim: To evaluate and analyze the donor deferral pattern and its causes among CP donors in a tertiary care hospital blood bank apheresis unit. Settings and Design: Hospital-based retrospective analysis. Subjects and Methods: Donors aged 18–65 years who had recovered from COVID-19 at least 4 weeks previously coming for plasma donation were retrospectively analyzed from July 25, 2020 to January 24, 2021 for a period of 6 months at blood bank apheresis unit, Assam Medical College and Hospital. Results: A total of 396 potential plasma donors were screened during the study period. The donor deferral rate was 39.1%. The permanent deferral was 36.8%, and the temporary deferral was 63.2%. The maximum number of donors deferred because of low antibody (18.7%) followed by low hemoglobin (14.8%). Associated comorbidities, low platelet count, repeat reverse transcription-polymerase chain reaction positivity, transfusion transmitted infection reactivity, intake of medicines, infections, vaccination, and underweight were other causes identified. Conclusion: The pattern of donor deferral is an important tool for blood safety and also provides key areas to focus on a demographic region or policy formulation for donor selection as well as to ensure donor safety.

Keywords: Convalescent plasma donor, donor deferral, permanent deferral, temporary deferral


How to cite this article:
Sharma A, Ahmed Z, Rahman M. Donor selection and deferral pattern in convalescent plasma donor in plasmapheresis unit of a tertiary care hospital. Assam J Intern Med 2021;11:20-3

How to cite this URL:
Sharma A, Ahmed Z, Rahman M. Donor selection and deferral pattern in convalescent plasma donor in plasmapheresis unit of a tertiary care hospital. Assam J Intern Med [serial online] 2021 [cited 2021 Oct 18];11:20-3. Available from: http://www.ajimedicine.com/text.asp?2021/11/2/20/327545


  Key Messages: Top


Donor counseling and screening through a questionnaire before a donation is an important process for a donor as well as recipient safety. Efforts must be taken to increase awareness among temporary deferred donors and to encourage them for future donations to retain the pool of convalescent plasma donors.


  Introduction Top


The novel coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which began in Wuhan, China, in December 2019. It has been declared a global pandemic by the World Health Organization (WHO) on March 11, 2020. COVID-19 resulted in more than 1.16 billion cases and 25.8 lakh deaths worldwide (data updated by WHO on March 7, 2021).

Currently, there are no approved treatments for COVID-19. The management plan is supportive care with supplemental oxygen and mechanical ventilation.[1] Numerous trials are being done across the world to assess the efficacy of various treatment modalities. Among the possible anti-COVID-19 treatments, the use of plasma from individuals who have recovered from SARS-CoV-2 infection has gained increasing responses on its safety and potential efficacy, particularly when administered early in critically ill COVID-19 patients.[2],[3],[4],[5] The postulated mechanism of action of COVID-19 convalescent plasma (CP) includes a process of passive immunization through the transfer of specific neutralizing antibodies from recovered individuals to COVID-19 patients.[6]

Historically, CP has been used in viral diseases such as poliomyelitis, measles, mumps, and influenza before vaccines became available.[7],[8],[9],[10],[11] A meta-analysis of 1703 patients with H1N1 influenza during the Spanish Flu of 1918 suggested that patients who received CP had lower mortality.[12] Conversely, in a double-blind, randomized, and placebo-controlled trial, CP was not found to be superior to placebo in patients infected with influenza A.[13],[14],[15] In a retrospective study of 80 patients during the previous coronavirus outbreak of SARS in 2002–04, it was observed that patients who received CP before day 14 of illness had better outcomes, defined as early hospital discharge, compared with patients who received it after day 14 of illness (15.6% vs. 58.3%; P < 0.001).[16] Considering the lack of efficacious treatments for COVID-19 and the epidemic situation with high mortality rate, US FDA has approved CP for COVID-19 for clinical trials, expanded access, and single-patient emergency investigational new drugs.[17]

Although numerous trials are currently investigating the safety and efficacy of CP in COVID-19 patients, there are very few ongoing and published studies evaluating the CP donors’ side. Little attention has been focused on the efforts to recruit COVID-19 CP (CCP) donations. The process of CCP donor recruitment has multiple required steps, including identification of persons recovered from the COVID-19, their eligibility to donate blood products, confirmation of anti-SARS-CoV-2 antibody status, and facilitation of plasma donation. An understanding of the process and challenges of CCP recruitment is important to aid efforts to meet community CCP demand. This study was undertaken to evaluate and analyze the donor deferral pattern and its causes among CP donors in a tertiary care hospital blood bank apheresis unit.


  Subjects and Methods Top


Donors aged 18–65 years who had recovered from COVID-19 at least 4 weeks previously coming for plasma donation were retrospectively analyzed from July 25, 2020 to January 24, 2021 for a period of 6 months.

Donors were recruited according to a hospital-based patient register. At the time of discharge, all recovered COVID-19 patients were counseled. They were motivated towards the donation of CP and its probable beneficial effects in the management of COVID-19 patients. Such patients were briefed in detail regarding their extent of participation in the study and encouraged to visit the blood bank for further evaluation toward eligibility for blood donation. When in need, the participants were provided conveyance for facilitating transport.

The following criteria were to be met for potential donors[17]:

  • 18–65 years of age group
  • Males or nulliparous female donors of weight >50 kg
  • Prior diagnosis of COVID-19 documented by a laboratory test (reverse transcription-polymerase chain reaction [RT-PCR]) with symptomatic disease with at least fever and cough
  • Complete resolution of symptoms at least 28 days before donation.


Individuals who seemed eligible and potentially interested in being donors were asked to undergo preliminary blood tests to detect anti-SARS-CoV-2 IgG antibodies before donation to avoid unnecessary donations. Donors were clinically evaluated to highlight any absolute contraindications to the apheresis procedure. All donors needed to check complete blood count and total serum protein and to be tested negative for hepatitis B and C viruses, human immunodeficiency virus, syphilis, and malaria. Donors were then explained the procedure of plasma donation and the adverse events associated with the process. Among the consenting donors and based on the results, accepted donors were asked to return on a specified date for plasma donation.

According to national transfusion laws, all donors were voluntary and unpaid. Plasma collection was performed in a dedicated facility, using the latest-generation cell separators (Fresenius Kabi), according to the donors’ characteristics, under the supervision of doctors. About 400mL of plasma was collected during each procedure and immediately divided into two bags of equal volume. Finally, the plasma was stored in a dedicated freezer at a controlled temperature ranging from −40°C to −80°C.

Donor adverse events were managed as per the trial site’s protocol for apheresis donations. Successful plasma donors were requested to repeat the donation after 2 weeks.


  Results Top


A total of 396 potential plasma donors were screened during the study period. Amongst 396 donors, 155 donors were deferred. The donor deferral rate was 39.1%. Out of 155 deferred donors, 142 were male (91.6%), and 13 were female (8.4%). Maximum donor deferral was seen in the age group 28–37 (36.8%), and the lowest was seen in the age group 48–57 (7.8%) [Table 1]. The maximum number of donors deferred because of low antibody (18.7%) followed by low hemoglobin (14.8%) [Table 2].
Table 1: Donor deferrals according to age group

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Table 2: Donor deferral reasons

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The permanent deferral rate was 36.8%, and the temporary deferral was 63.2%. Among the causes of permanent donor deferral, low antibody (18.7%) was the most common reason, followed by high blood pressure (7.10%). The most common cause of temporary deferral was low hemoglobin (below 12.5 g%) among 14.8% (23/155) of the deferred blood donors. Among deferred donors, 3.20% were found to be RT-PCR positive [Table 2]. Low platelet count, transfusion transmitted infection reactivity, history of typhoid, intake of medicines, infections, vaccination, underweight, and last blood donation within 3 months were other causes identified.


  Discussion Top


Donor counseling and screening through a questionnaire before the donation is an important process for a donor as well as recipient safety. The deferred donors were informed about the reason for deferral and counseled accordingly. It is important to analyze the donor deferral criteria in specific demographic areas unique to the area to develop a safe pool of CP donors as well as to bring back donors deferred due to temporary causes and keep them motivated. Low hemoglobin levels were the most important reason for temporary deferral. Thus, combining anemia prevention and treatment in donor recruitment strategies could help regain the donors and develop a healthy CP donor pool. Deferral is a form of rejection and also could be a representation of loss of time for both CP donors and blood banks, and the importance of explaining the status of deferral cannot be ignored.[18] Efforts must be taken to increase awareness among temporary deferred donors and to encourage them for future donations. This can help retain a pool of motivated CP donors.

This study emphasizes the recruitment of CP donations in the current and future pandemics. Recruitment of CP donors’ process includes not only education but also motivation to overcome the perceived stigma of infection and the fear of repeat RT-PCR test. The authors hope that an individual’s readiness for donating CCP may improve over time. Although we contacted candidates within 3–4 weeks after discharge from the hospital, many individuals were still feeling the effects of the disease and were not physically or emotionally ready to consider donating. Computer applications may potentially automate the screening of hospitalized COVID-19 patients, helping recruitment teams to focus on patients eligible for CCP donation.

Limitations of our study include its retrospective nature and the relatively limited time span. This report focuses on the procurement of CCP, but not on the effectiveness of the therapy.

Acknowledgments

The authors especially thank all the individuals who, with civic sense, agreed to donate plasma. The authors are also thankful to Dr. Sanjeeb Kakati, Principal, Assam Medical College & Hospital, for assistance during the preparation of the article.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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Joyner MJ, Wright RS, Fairweather D, Senefeld JW, Bruno KA, Klassen SA, et al. Early safety indicators of COVID-19 convalescent plasma in 5000 patients. J Clin Invest 2020;130:4791-7.  Back to cited text no. 5
    
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Park WH. Therapeutic use of anti-poliomyelitis serum in pre-paralytic cases of poliomyelitis. JAMA 1932;99:1050-3.  Back to cited text no. 7
    
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Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: Passive immunotherapy for influenza and other serious infections. Crit Care Med 2010;38:e66-73.  Back to cited text no. 8
    
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Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: Convalescent blood products for Spanish influenza pneumonia: A future H5N1 treatment? Ann Intern Med 2006;145:599-609.  Back to cited text no. 12
    
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Liu G, Li S. Convalescent plasma: A valid option in the treatment of COVID-19? Insights Clin Cell Immunol 2020;4:001-2.  Back to cited text no. 13
    
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Davey RT Jr, Fernández-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, et al; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): A double-blind, randomised, placebo-controlled trial. Lancet Respir Med 2019;7:951-63.  Back to cited text no. 14
    
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Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, et al; IRC005 Study Team. Anti-influenza immune plasma for the treatment of patients with severe influenza A: A randomised, double-blind, phase 3 trial. Lancet Respir Med 2019;7: 941-50.  Back to cited text no. 15
    
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Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis 2005;24:44-6.  Back to cited text no. 16
    
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US Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma;2020. Available from: http://www.fda.gov/vaccines-blood-biologics/ investigational-new-drug-applications-inds-cber-regulated-products/recommendations-investigational-covid-19-convalescent-plasma. [Last accessed on 2020 April 10].  Back to cited text no. 17
    
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Jashnani KD, Patil LN. Blood donor deferrals: Can this be reduced? Asian J Transfus Sci 2011;5:60.  Back to cited text no. 18
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