Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kathirvel Subramaniam
• Collaborators: CSL Behring; University of Maryland; University of Maryland, College Park
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• Be willing and able to provide written informed consent.

• Be at least 18 years of age.

• Patients with or without ventricular assist device (VAD) undergoing heart transplantation

• Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.

• International normalization ration (INR) greater than or equal to 1.5

• Body temperature greater than 35.0 degrees Celsius.

• Blood pH greater than 7.2

• Hemoglobin greater than 7.0 mg/dL.

Exclusion Criteria:

• Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.

• Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.

• Ischemic or thromboembolic events within 6 weeks of study surgery.

• Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.

• Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.

• Patients on respiratory support including extracorporeal membrane oxygenation (ECMO) .

• Life expectancy less than 48 hours.

• Excluded at the discretion of the surgeon based upon surgical safety precautions