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Terminated
NCT03341156
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
Conditions: Heart Disease End Stage, Heart Failure,Congestive
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 14
Sponsor: University of Maryland, Baltimore
Location: University of Maryland Baltimore Maryland
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT03341156). StuddyBuddy aggregates publicly available trial information.