Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in P… (NCT05711524) | Clinical Trial Compass
CompletedPhase 4
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
United States208 participantsStarted 2023-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
✓. Cardiovascular surgery includes the following procedures:
✓. coronary artery bypass grafting
✓. valve repair or replacement
✓. open thoracic aortic and thoracoabdominal aortic surgery
✓. atrial or ventricular septal defects
✓. ventricular assist device implantation or revision
✓. or any combination of the above.
Exclusion criteria
✕. Patients who do not receive any cryo product in the OR
✕. Patients who are not cardiovascular surgery or liver transplant patients
✕
What they're measuring
1
Total Number of RBCs Used Over Admission
Timeframe: Within the first 30 days after surgery.
2
Total Number of Platelets Used Over Admission
Timeframe: Within the first 30 days after surgery.
3
Total Number of Plasma Used Over Admission
Timeframe: Within the first 30 days after surgery.
Trial details
NCT IDNCT05711524
SponsorWeill Medical College of Cornell University
✕. 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.
✕. Patients who receive less than 1 pool (5 units) of cryo
✕. Pediatric patients (less than 18 years of age).
✕. Patients who received both PR cryo and traditional cryo