In vitro quality parameters of whole blood‐derived platelets pooled using two different platelet pooling sets and stored up to 7 days are similar

Author:

Vandenbroeke Tania1ORCID,Gloor Christina1,Wingfield Tyler1,Leite Caroline2,Carr Kathlynn3,Turner Chris3,Ngamsuntikul Samantha3,Sutor Laurie4,Compton Frances4ORCID,Nestheide Shawnagay5,Rugg Neeta5,Cancelas Jose A.5,Dumont Larry J.26ORCID

Affiliation:

1. Research & Development Terumo BCT, Inc. Lakewood Colorado USA

2. Vitalant Research Institute Vitalant Denver Colorado USA

3. Administrative and Components Divisions South Texas Blood & Tissue San Antonio Texas USA

4. Department of Medical Services Carter BloodCare Bedford Texas USA

5. Hoxworth Blood Center University of Cincinnati College of Medicine Cincinnati Ohio USA

6. Department of Pathology University of Colorado School of Medicine Aurora Colorado USA

Abstract

AbstractBackgroundIncreasing the number of collections of whole blood‐derived platelets (WBDP) and lengthening the allowable storage time may alleviate platelet (PLT) shortages. There is a need for new PLT pooling sets that can provide acceptable quality on Day 7 of storage.Study Design and MethodsThis pool‐and‐split study compared WBDP prepared using the platelet‐rich plasma method with the novel IMUGARD WB PLT pooling set and a control pooling set. After pooling and filtration, PLT products were tested on Days 1, 5, and 7. Large volume delayed sampling (LVDS) cultures were taken on Day 2.ResultsThe median postfiltration residual white blood cell (rWBC) content was 0.18 million per product (maximum 1.26 million; n = 69) with mean PLT recovery of 88.5 ± 2.8% for the new set and median 0.23 million (maximum 1.83 million) rWBC with 87.5 ± 2.5% recovery for the control. Day 5 mean pH22°C were 7.18 ± 0.12 and 7.13 ± 0.10 for the new and control set, respectively. Day 5 in vitro quality parameters were within 20% between the two pooling sets. The new set Day 7 pH22°C was acceptable (7.07 ± 0.17, 100% ≥ 6.3), and most parameters were within 20% of Day 5 values.ConclusionWBDP quality for the new pooling set is acceptable across a battery of in vitro tests when stored up to 7 days and meets FDA regulatory criteria. The quality parameters were similar between the new pooling set and the control set on Day 5. This new set is compatible with LVDS.

Funder

Terumo BCT

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Reference11 articles.

1. The current state of the platelet supply in the US and proposed options to decrease the risk of critical shortages

2. Slowing decline in blood collection and transfusion in the United States–2017;Jones JM;Transfusion,2020

3. Outdate reduction and cost savings with rapid testing for seven‐day platelet storage;Mintz PD;Ann Clin Lab Sci,2020

4. U.S. Food & Drug Administration.Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. December 2020.

5. A multi-laboratory evaluation of in vitro platelet assays: the tests for extent of shape change and response to hypotonic shock. Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion

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