Establishing a sustainable protocol for massive transfusion using thawed plasma and cryoprecipitate reconstituted from expired thawed plasma

BACKGROUND: In Japan, thawed plasma (TP) is not used because of the short expiration time of fresh frozen plasma (FFP) post-thawing. We developed and implemented a new massive transfusion protocol (MTP) using TP and expired TP and evaluated its impact on plasma waste, transfusion response times, and patient outcomes. STUDY DESIGN AND METHODS: Phase 1: From November 2023 to March 2024, we investigated the clinical use of TP and the expiration rate of TP derived from 480 mL of FFP (blood type: AB). The cryoprecipitate was prepared from expired TP (TP-CRYO), and its coagulation factors were measured. Phase 2: From April 2024 to March 2025, TP-CRYO was incorporated into a regular stock of type-AB cryoprecipitate and administered to patients with massive bleeding. Clinical data, fibrinogen levels, and adverse events were investigated in patients who received TP and in those who received cryoprecipitate, including TP-CRYO. RESULTS: During phase 1, TP was administered to 11 patients and 22 bags of TP expired. Compared with the conventionally prepared cryoprecipitate, TP-CRYO had slightly higher clotting activity and fibrinogen levels. During phase 2, TP was administered to 55 patients, using 42 bags of expired TP. One bag of TP-CRYO was discarded owing to early patient transfer, one due to fibrin formation, and three remained in stock. The other 37 were administered. The plasma waste rate decreased from 66.7% to 2.1%. No direct adverse events were associated with TP or TP-CRYO use. DISCUSSION: We established a sustainable MTP using TP and in-house cryoprecipitate from TP-CRYO.