Overview

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