Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding

22-04024649

The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. Participants will be given one of the two FDA-approved blood products.

2023-04-01

2024-03-01

2025-03-01

Recruiting

Early phase I

302

Inclusion Criteria: 1. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period. 2. Cardiovascular surgery includes the following procedures: 1. coronary artery bypass grafting 2. valve repair or replacement 3. open thoracic aortic and thoracoabdominal aortic surgery 4. atrial or ventricular septal defects 5. ventricular assist device implantation or revision 6. or any combination of the above. Exclusion Criteria: 1. Patients who do not receive any cryo product in the OR 2. Patients who are not cardiovascular surgery or liver transplant patients 3. Cardiac transplantation surgery 4. Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month. 5. Patients who receive less than 1 pool (5 units) of cryo 6. Pediatric patients (less than 18 years of age). 7. Patients who received both PR cryo and traditional cryo 8. Pregnant women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention and randomization are not made at the level of the individual patient, but rather on clusters of patients by month. The clusters will include all patients at NYP/WC for whom pooled cryo is ordered during a single month.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 302, 'type': 'ESTIMATED'}}

2023-10-03