November 07, 2022
Adverse reaction (AR) reporting for blood collections and transfusions has long been standardized at the national level, identifying trends and providing lessons to improve donor and patient safety. In contrast, tracking of ARs related to therapeutic apheresis procedures or cellular collections is far less standardized. Historically, ARs were reported and investigated at the regional level.
Eric Gehrie, MD, presented data from a trial of AR tracking for CT collections using standardized definitions at 11 American Red Cross (ARC) stem cell collection locations nationwide. The approach is modeled on AR tracking for blood collections/transfusions. Gehrie is the executive physician director for direct patient care and emerging cell and gene therapy solutions at ARC. The study results were presented at the Monday oral abstracts session (AM22-14-L) on PBM, hemovigilance and education.
Over a 13-month period, 7,279 cellular collections were performed with fewer than 1% of total CT procedures resulting in reported ARs. Of the reported events, central line complications, vasovagal events, and hematomas were the most common. The overall reported AR rate was 38.5 events per 10,000 apheresis collection procedures.
The national AR tracking program for ARC cellular collections included stem cell collection procedures, collections for CT starting material, and allogeneic collections for CT starting material, along with licensed CAR T cells, sipuleucel-T treatment, healthy paid donors, and clinical trials. Standardized AR categories were applied: citrate toxicity, hematoma or infiltration, vasovagal response, allergic reaction, central line complication, hemolysis, air embolism, cardiac arrest, respiratory arrest, arterial puncture, nerve irritation, injury, or other.
A job aid — with information about the causes, signs, symptoms, and management of collection-related ARs — was developed and made available to all program staff, who perform or monitor procedures or review patient complication records.
Seven of the ARs required treatment at an outside facility. Of these six were categorized as “other.” Two were primarily associated with central lines; two were primarily leaking tubing sets; one was due to a clot in the collection bag; one was due to fluid-responsive hypotension of unclear etiology.
Overall, the number of ARs per 10,000 was 8.4 for central line,5.9 other, 6.7 vasovagal, 8.4 large hematomas, 2.5 citrate toxicity, 0.8 patient injury.
“As transfusion medicine continues to grow in CT arena, application of hemovigilance principles to CT is indicated,” said Gehrie.
The researchers hypothesize that analysis of outlier events and trends will help to continually improve CT collection processes.
ARC is continuing the initiative. This winter the system will allow national reporting of ARs that occur during therapeutic apheresis procedures (plasma exchange, RBC exchange).