key: cord-1016485-doimwmcd
authors: Vossoughi, Sarah; Schwartz, Joseph
title: Non-Evidence Based Platelet Transfusions for Protocol Eligibility
date: 2020-05-03
journal: Cytotherapy
DOI: 10.1016/j.jcyt.2020.04.094
sha: bbac3aee9fca842f5489330ba04780f4942fa3b8
doc_id: 1016485
cord_uid: doimwmcd

nan

The recent pandemic of a novel Coronavirus has brought the need for more aggressive blood conservation strategies to the forefront of many hospital disaster management policies. In particularly short supply are platelets. Platelet transfusions are one of the higher risk, high cost, and low availability blood components to transfuse. This is due to the fact that they are stored at room temperature in plasma creating the perfect medium for bacteria. This type of storage preserves structure and function but necessitates short outdates, wastage, additional testing, and is expensive. Despite all of the additional precautions , the reported rate of transfusion transmitted infections remains > 3 times higher in platelets compared to red cell products; and transfusion related acute lung injury (TRALI) is almost 4 times higher in female vs. male donated products. [1] [2] To address the infectious risk, pathogen-inactivation technologies are now widely used in many countries, but this also increases the cost in addition to decreasing the number of available doses due to platelet loss during processing. 3 It is because of these patient risks and inventory challenges that many transfusion services have strict evidence based criteria for transfusion that are frequently audited.

For patients in our institution, the transfusion threshold for a single dose of platelets (1 single donor platelet product, approximately 3x10 11 platelets) in non-bleeding patients not undergoing invasive procedures is 10,000/µL as there has been no demonstrated benefit in higher doses or higher transfusion thresholds. 4 During a routine audit review, we discovered a trend of these guidelines being disregarded specifically in clinical trial patients. Upon further investigation, we observed a trend of bioindustry cellular therapy trials establishing arbitrary non-evidence based guidelines for transfusion. Of 86 clinical trial records for cellular therapies covering 19 protocols, 67% of released platelets did not meet hospital transfusion guidelines established by an interdisciplinary team of experts compared to only 18% out of guideline release in patients who were not on a cellular therapy protocol. Platelet transfusion thresholds for the clinical trials ranged from 20,000-150,000/µL (median 50,000) with no literature cited to justify these increased thresholds.

It has been a decade since Callum et al 5 pointed out the need for a formal process regarding transfusions for study eligibility. It is now time to reconsider blindly following 'for clinical trial' guidelines and question protocols that do not follow the standards of care established for other patients. This is important both for the greater good of conserving this rapidly depleted resource during shortages and also during routine operations for the well-being of our patients and study subjects to whom we owe only the highest standard of care as physicians.

Transfusiontransmitted infections reported to the National Healthcare Safety Network Hemovigilance Module

Ten years of TRALI mitigation: measuring our progress

Blood utilisation and transfusion reactions in adult patients transfused with conventional or pathogen-reduced platelets

Dose of prophylactic platelet transfusions and prevention of hemorrhage

Transfusion for protocol eligibility

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Dr. Sarah Vossoughi performed the literature review, contributed significantly to the conception, design, and implementation of the reported audit process, and drafted the submission.Dr. Joseph Schwartz contributed significantly to the literature review, the conception, design, and implementation of the audit, reviewed and revised the draft, and acted as the senior author.Both authors have approved the final submission.