Stanford Health Care Cupertino, California, United States
Background/Case Studies: Cryoprecipitated anti-hemophilic factor (Cryo AHF) has been used for fibrinogen replacement in actively bleeding patients, in addition to its use in dysfibrinogenemia and hypofibrinogenemia. Cryo AHF has a shelf life of 4-6 hours after thawing, posing a major limitation of its use. Therefore, Cryo AHF is thawed as needed to prevent waste, but this can increase the turnaround time (TAT) in treatment of coagulopathic patients. In November 2020, the FDA approved Pathogen Reduced Cryoprecipitated Fibrinogen Complex (also known as INTERCEPT® Fibrinogen Complex, IFC) for the treatment of bleeding associated with fibrinogen deficiency. IFC can be stored at room temperature and has a shelf life of 5 days after thawing.
Study
Design/Methods: We identified locations and specific end-users with high Cryo AHF utilization and waste. We partnered with our blood supplier to replace Cryo AHF with IFC in these locations. We aimed to analyze the waste, TAT, and cost impacts of IFC implementation.
Results/Findings: Adult cardiac surgeries and liver transplants had the highest Cryo AHF utilization and the adult operating rooms (ORs) had a waste rate that exceeded non-operative locations. Pre-IFC implementation, operative locations had a 17% Cryo AHF waste rate compared to 3% waste in non-operative locations. This was largely due to Cryo AHF being thawed at the time of request from the OR which created a practice of anticipatory ordering. IFC was added to our inventory to replace all Cryo AHF orders from adult ORs, and the waste rate decreased significantly. Post-implementation, IFC waste was 1.8% in ORs, Cryo AHF waste in non-operative locations was 4%, and overall waste of cryoprecipitated products across all locations at the adult hospital was reduced from 10% to 3.5%. The intraoperative TAT for cryoprecipitated products was reduced by 58% from the time when the transfusion request was received to the time of product issue. Despite the increased cost of IFC relative to Cryo AHF, the waste reduction has reduced overall cost and analysis is ongoing as we monitor several factors, including base unit cost, reimbursement from new technology add-on payments (NTAP), and waste rates. Conclusions: IFC has enabled us to maintain an inventory of a thawed cryoprecipitated product, which has improved utilization efficiency and turnaround time. There has been a substantial decrease in waste since IFC can be returned to the inventory when unused. Additionally, this improved TAT may allow for IFC to be considered as a source of fibrinogen replacement in massive bleeding and to be included in pre-defined massive transfusion protocols. Further multi-institutional studies are needed to show similar evidence and demonstrate clinical efficacy of IFC in these settings.
Importance of research: Pathogen reduced cryoprecipitated fibrinogen complex (IFC) has been recently approved by the FDA in 2020. It has the potential to improve utilization efficiency, reduce wastage and have an overall cost benefit compared to Cryo AHF and fibrinogen concentrates. Additionally, the impact of fibrinogen in massive bleeding especially from trauma is being studied extensively. IFC can be used for this purpose since it is readily available unlike Cryo AHF which needs to be thawed.
