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

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.

Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions.

Background: Apheresis technology to collect platelet (PLT) components differs among devices. We evaluated the relationship of the plateletpheresis device with bacterial contamination and reported septic transfusion reactions.

Study Design And Methods: Plateletpheresis was performed using Amicus (Fenwal, a Fresenius Kabi Company) or Trima (Trima Accel, TerumoBCT) from 2010 to 2014.

Predicted effect of selectively testing female donors for HLA antibodies to mitigate transfusion-related acute lung injury risk from apheresis platelets.

Background: The use of male-donor-predominant plasma has reduced the risk of transfusion-related acute lung injury (TRALI), but the possible benefit of different mitigation strategies for other components is unknown. We evaluated the risk of TRALI from apheresis platelets (PLTs) to predict the effect of selectively testing female plateletpheresis donors who have been pregnant for HLA antibodies.

Study Design And Methods: The American Red Cross hemovigilance program classified TRALI cases from apheresis PLTs or red blood cells (RBCs) in 2006 to 2013 or from predominantly male-donor (>95%) plasma in 2008 to 2013 and compared the component-specific TRALI rates.

Clostridium perfringens in apheresis platelets: an unusual contaminant underscores the importance of clinical vigilance for septic transfusion reactions (CME).

Background: Posttransfusion sepsis is typically caused by aerobic bacteria in apheresis platelets (PLTs) that escape detection by routine quality control cultures performed on every donation before components are distributed. We report the first case to implicate an anaerobic isolate, Clostridium perfringens, in apheresis PLTs and investigate its detection in vitro by approved tests.

Study Design And Methods: The C.

The residual risk of transfusion-related acute lung injury at the American Red Cross (2008-2011): limitations of a predominantly male-donor plasma mitigation strategy.

Background: The American Red Cross began preferentially distributing plasma from male donors in 2007 and subsequently observed an 80% decrease in reported cases of transfusion-related acute lung injury (TRALI) after plasma transfusion. Plasma distributions from male donors now exceed 99% for groups A, B, and O, but only approximately 60% for group AB. We evaluated the ongoing risk of TRALI and the ABO blood group of involved plasma donors.

Improved safety for young whole blood donors with new selection criteria for total estimated blood volume.

Background: Young age, first-time donation status, and estimated blood volume (EBV) are leading determinants of syncopal complications after whole blood donation. We evaluated a multifaceted safety initiative and more restrictive selection criteria for whole blood donation by individuals younger than 19 years.

Study Design And Methods: Measures introduced over 2 years addressed donor education, drive environment and supervision, and new eligibility criteria for EBV of 3.

The relative safety of automated two-unit red blood cell procedures and manual whole-blood collection in young donors.

Background: Automated red blood cell (RBC) apheresis offers the advantage of collecting 2 units of RBCs (2RBC) from one donation, but may expose donors to procedure-related risks. This study evaluated the relative safety of 2RBC compared to whole-blood (WB) donation with a focus on young donors.

Study Design And Methods: Adverse reactions recorded at the collection site or requiring outside medical care were compared after 4,348,686 WB and 206,570 2RBC donations in 26 regional blood centers.

Limiting and detecting bacterial contamination of apheresis platelets: inlet-line diversion and increased culture volume improve component safety.

Background: Septic transfusion reactions to apheresis platelets (PLTs) continue to occur despite preventive measures. This study evaluated the effect of two operational changes designed to reduce bacterial risk: 1) introducing inlet-line sample diversion on two-arm procedures and 2) increasing the sample volume cultured from 4 to 8 mL from all donations.

Study Design And Methods: Aerobic culture results and septic transfusion reactions reported between December 1, 2006, and July 31, 2008 (Period 2), were compared to March 1, 2004, to May 31, 2006 (Period 1).

Bacterial contamination of whole-blood-derived platelets: the introduction of sample diversion and prestorage pooling with culture testing in the American Red Cross.

Background: Bacterial sepsis following whole blood-derived platelet (WBP) transfusion has remained a substantial patient risk, primarily due to a lack of practical and effective means to limit or detect bacterial contamination. We describe the risk of reported septic reactions to WBPs and the introduction of prestorage-pooled whole blood-derived platelets (PSPs) collected using initial sample diversion and cultured for bacterial contamination.

Study Design And Methods: Product qualification and quality control (QC) testing with the Acrodose PL system (Pall Medical) were evaluated in four regional blood centers.

The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006.

Background: The American Red Cross (ARC) initiated a comprehensive donor hemovigilance program in 2003. We provide an overview of reported complications after whole blood (WB), apheresis platelet (PLT), or automated red cell (R2) donation and analyze factors contributing to the variability in reported complication rates in our national program.

Study Design And Methods: Complications recorded at the collection site or reported after allogeneic WB, apheresis PLT, and R2 donation procedures in 36 regional blood centers in 2006 were analyzed by univariate and multivariate logistic regression.

Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds.

Context: Donations by minors (16- and 17-year-olds) now account for approximately 8% of the whole blood collected by the American Red Cross, but young age and first-time donation status are known to be independent risk factors for donation-related complications.

Objective: To evaluate adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds compared with older donors in American Red Cross blood centers.

Design, Setting, And Participants: Prospective documentation of adverse events among 16- and 17-year-old donors using standardized collection protocols, definitions, and reporting methods in 2006.

Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004-2006).

Background: The American Red Cross initiated systemwide bacterial testing of all apheresis platelet (PLT) collections in March 2004, yet continues to receive reports of septic reactions after transfusion of screened components.

Study Design And Methods: The rates of confirmed bacterial contamination of apheresis PLT collections detected by prospective quality control (QC) testing, and by surveillance of reported septic reactions to screened-negative apheresis PLTs, were analyzed according to the technology utilized for collection.

Results: Between March 1, 2004, and May 31, 2006, bacterial culture testing was performed on 1,004,206 donations; of these, 186 (1:5,399) had confirmed-positive culture results.