Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce allogeneic blood product use and decrease unnecessary laboratory costs. One of the NYPH Quality and Patient Safety Goals for 2013 was to improve the appropriate use of transfusion guidelines and reduce unnecessary red blood cell (RBC) transfusions. Further, this study will help to answer whether RiaSTAP is a more effective product to treat bleeding than cryoprecipitate. In addition, this trial will provide investigators with preliminary data to apply for future federal funding opportunities, such as the National Heart Lung and Blood Institute sponsored R21 grant (PAR-13-025) that encourages research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine. The investigators anticipate future follow-on studies further investigating fibrinogen concentrate and other similar therapeutics in other perioperative populations, such as in postpartum hemorrhage or surgical ICU settings. Finally, this study involves the use of a safer therapeutic, fibrinogen concentrate, to improve patient care and patient safety. This product does not require the time-intensive process of thawing; therefore, delays in patient care can be avoided by having the product readily available in the OR.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University

Criteria

Inclusion Criteria:

1. All subjects age 18 and older who have given written informed consent

2. Undergoing cardiac surgery cardiopulmonary bypass (CBP) at Weill Cornell Medical Center

Exclusion Criteria:

1. Subjects on anticoagulation medications including:

• Clopidogrel, ticagrelor, prasugrel with platelet function analyzer-100 assay closure time (CT) prolonged greater than 15%

• Last doses of dabigatran, rivaroxaban, apixaban within 72 hours

• Warfarin with international normalized ratio (INR) greater than 1.5

2. Positive pregnancy test, pregnancy or lactation

3. Thrombocytopenia: platelet count less than 100,000 u/L

4. Emergency procedures

5. Proof or suspicion of a congenital or acquired coagulation disorder (e.g. von Willebrand Factor or via severe liver disease)

6. Participation in another randomized clinical trial