Status:
TERMINATED
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
CSL Behring
Conditions:
Heart Disease End Stage
Heart Failure，Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 f...
Detailed Description
This study will be a randomized (1:1; PCC vs. plasma), open-label trial of hemostatic therapies during heart transplantation. The goal is to enroll 60 patients. Informed consent will be obtained from ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03341156
Start Date
July 11 2018
End Date
February 20 2025
Last Update
May 23 2025
Active Locations (3)
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1
University of Maryland
Baltimore, Maryland, United States, 21201
2
Upmc Presbyterian Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
3
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15213