Fibrinogen retention and hemostatic quality of pathogen reduced cryoprecipitate stored at room temperature, 5-days post thaw
Abstract Number: T-32
Abstract Type: Original Research
BACKGROUND: Postpartum hemorrhage (PPH) continues to be a significant cause of morbidity and mortality worldwide accounting for almost 25% of maternal deaths.1 Fibrinogen (FB) levels are a marker of PPH severity3 which has led to studies looking at Fb therapy as a means to control hemorrhage. Cryoprecipitate (cryo) is an enriched source of fibrinogen (FB), Factor XIII, Factor VIII and von Willebrand Factor (vWF). Today’s pooled cryo poses risk of transfusion transmitted infection from bacteria, known and unknown pathogens. Because of the risk of bacterial growth, cryo’s post-thaw shelf life is 4-6 hours. We assessed hemostatic quality and retention of coagulation factors in pathogen reduced (PR) cryo. METHODS: Six units of whole blood derived (WBD) FFP were produced by pooling type-matched FFP from 3 different donors and dividing each pool into a Test Jumbo FFP (625 ± 25 mL) and an untreated Control (230 mL). Six replicates of apheresis (Aph) plasma were each produced by pooling 2 Aph collections and dividing each pool as described above. All Test units were PR using UVA light and psoralen treatment. Cryo was manufactured according to blood center SOPs and frozen at -30°C with residual supernatant (60 mL for Test and 20 mL for Control). Cryo was thawed at 37°C and sampled (Day 0) then stored at 22˚C and sampled aseptically again at 1 and 5 days post-thaw. FVIII and FB activity were measured using an automated coagulation analyzer. Antigen levels were measured by ELISA for Factor XIII and vWF. Samples were evaluated using ROTEM’s INTEM and EXTEM assays and thrombin generation (TG). RESULTS: FB and FXIII levels in PR cryo remained constant up to 5 days post-thaw when stored at 22˚C, regardless of plasma source (Table 1). FVIII activity declined over storage for both PR derived and control cryo in both WBD and Aph source plasma. Approximately, 95% ± 3 of FB was retained in PR Aph cryo stored for 5 days and 104% ± 6 retained in WBD PR cryo. Similar values were seen for FXIII and vWF. Hemostatic function of PR cryo, using ROTEM and TG analysis also showed equivalence with Control at days 1 and 5. CONCLUSION: Cryo prepared from PR plasma showed consistent FB and FXIII yields up to 5 days post-thaw, compared to untreated cryo. Preparation of cryo from PR plasma could potentially extend thawed storage, thereby reducing product wastage and increasing FB availability for urgent use, with the added advantage of a reduced risk of transfusion-transmitted infection.