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NCT05711524
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Conditions: Hypofibrinogenemia, Bleeding
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 302
Sponsor: Weill Medical College of Cornell University
Location: United States
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.
Eligibility Criteria
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 graftingvalve repair or replacementopen thoracic aortic and thoracoabdominal aortic surgeryatrial or ventricular septal defectsventricular assist device implantation or revisionor any combination of the above.Exclusion Criteria:Patients who do not receive any cryo product in the ORPatients who are not cardiovascular surgery or liver transplant patientsCardiac transplantation surgeryPatients 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 cryoPediatric patients (less than 18 years of age).Patients who received both PR cryo and traditional cryoPregnant women
Source: ClinicalTrials.gov (NCT05711524). StuddyBuddy aggregates publicly available trial information.