Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events

Townsend, Mary; Kamel, Hany; Buren, Nancy Van; Wiersum‐Osselton, Johanna C.; Rosa-Bray, Marilyn; Gottschall, Jerome L.; Rajbhandary, Srijana

doi:10.1111/trf.15830

Cited by 17 publications

(25 citation statements)

References 14 publications

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“…To our knowledge, this is the first multi-institutional DHV study to employ the SGT since its introduction. 13 This study has several limitations. First, as a survey study with few participants, we acknowledge the potential for sampling bias toward the experience of CCP collection at nonprofit blood centers.…”

Section: Discussionmentioning

confidence: 92%

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The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study

Cho¹,

Rajbhandary

Buren

et al. 2021

Transfusion

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Background: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context.Study design and methods: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. Results: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. Conclusion:The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

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Section: Discussionmentioning

confidence: 92%

“…11 Severity grading classification was determined using the SGT. 13 Donations with more than one associated DAE were counted as separate events. Discrepancies in DAE type and category were harmonized to SSCRBD after follow-up with the participating organization.…”

Section: Methodsmentioning

confidence: 99%

The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study

Cho¹,

Rajbhandary

Buren

et al. 2021

Transfusion

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“…A donor adverse event severity grading tool has recently been developed and validated by a subgroup of the AABB Donor Hemovigilance Working group with international participation and approval, including endorsement from the European Blood Alliance. The donor adverse event severity grading tool was designed to be used with the definitions in the 2014 ‘Standard for Surveillance of Complications Related to Blood Donation’ to improve objective assignment of donor adverse event severity grade and provides the opportunity to further enhance global hemovigilance efforts 9 . Lastly, there could be variation in donor center practice as seen in Table 1 with age and weight limits and collection volumes.…”

Section: Discussionmentioning

confidence: 99%

Frequency of rare, serious donor reactions: International perspective

et al. 2021

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Background Severe blood donor adverse events are rare, but due to their rarity studying them can be difficult. To get an accurate estimate of their frequency and rate in the donor population it may be necessary to combine donation data across countries. Study Design and Methods International blood collection organizations (BCOs) provided data on rare/severe donor reactions as well as denominator information for their donor populations from 2015 to 2017. Donor reactions were classified using standardized definitions. Results BCOs from six countries provided reaction data for more than 22 million donations. A total of 480 rare reactions were reported of which 76.7% were imputed as definite and 11% probable. Rates of rare reactions were higher in females and first‐time donors. Systemic rare reactions were the most common reaction type, accounting for over three quarters of reactions reported. Of systemic reactions, vasovagal reactions with loss of consciousness and injury or off‐site (n = 350) made up the majority and occurred 1.53 per 100,000 donations. For the 22.3% that were localized reactions, the majority of these were cellulitis (n = 71, 0.31 per 100,000 donations) followed by deep venous thrombosis (n = 21, 0.09 per 100,000 donations). Conclusion Pulling together data from multiple BCOs across countries allows for a better understanding of rare reactions, such as vasovagal reaction with injury or cellulitis, and for generating a reliable incidence rate for air embolism or compartment syndrome. However, gaps remain due to missing elements such as unknown donor status or location of reaction.

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“…However, even where standard criteria are given, wide variations exist as is seen in the voluntary data on complications of blood donation which are reported annually to the European Commission [10]. The need for additional guidance was recently addressed by a Working Group of the AABB with representation of IHN and ISBT, which developed and validated a tool modelled on the pharmacovigilance Common Terminology Criteria for Adverse Events [11]. The tool is intended as an appendix to the revised definitions and provides complication-specific as well as generic criteria and explanations to support severity classification of blood donation complications into five grades, which broadly correspond to mild, moderate, severe, life-threatening or death.…”

Section: Discussionmentioning

confidence: 99%

Complications of blood donation reported to haemovigilance systems: analysis of eleven years of international surveillance

et al. 2020

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Background and Objectives The International Haemovigilance Network collects aggregate data on complications of blood donation from member haemovigilance systems (HVS). We analysed the data collected in 2006-2016 in order to learn from it and consider future improvements. Materials and MethodsNational HVS entered annual data on donation complications and on annual whole blood and apheresis donations in the 'ISTARE' (International Surveillance of Transfusion Adverse Reactions and Events) online database. We calculated national and aggregate donation complication rates.Results Twenty-four HVS provided data for 138 country years (CY; median 7 CY, IQR 2-8), covering 155 M donations. The overall complication rate was 6Á3/1000 donations and the median country rate 3Á2/1000 (IQR 1Á1-10Á1). Overall and severe complication rates varied considerably between HVS. Vasovagal reactions (VVR) were most commonly reported: 4Á6/1000 donations, median country rate 3Á1/1000 donations (IQR 0Á6-7Á7). Rare complications included generalized allergic reaction (0Á10/100 000) and major blood vessel injury (category available since 2015; 0Á12/ 100 000). Eighteen HVS reported complications of whole blood donation (WBD) and apheresis separately (89 CY, 101Á6 M WBD and 26Á3 M apheresis donations). The median country VVR rate was 3Á4/1000 WBD (IQR 1Á0-9Á1) and 1Á5/1000 apheresis donations (1Á0-4Á2). Rates of venepuncture-related complications tended to be higher for apheresis: the median country rate of reported haematomas was 0Á39/1000 WBD (IQR 0Á31-1Á2) vs. 4Á2/1000 apheresis donations (0Á69-5Á6). ConclusionInternational reporting allows HVS to study rates of blood donation complications and capture information about very rare events. The present variability of reporting and severity assessment hampers comparisons between HVS and requires further work.

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Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events

Cited by 17 publications

References 14 publications

The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study

The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study

Frequency of rare, serious donor reactions: International perspective

Complications of blood donation reported to haemovigilance systems: analysis of eleven years of international surveillance

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