Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
Megadott ok: Standard practice change prohibited enrollment
Key facts
- Where
- Baltimore és Pittsburgh, Egyesült ÁllamokSee the 3 sites
- Phase
- 3. fázis
Where in Egyesült Államok
- University of MarylandBaltimore, Egyesült ÁllamokNo longer taking part
- Upmc Presbyterian Montefiore HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
- UPMC Presbyterian ShadysidePittsburgh, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- University of Maryland, Baltimore
- Trial code
- NCT03341156
- Record updated
- 2026. november 10.
- Original description
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.Read full original descriptionShow less
Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
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.
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; Ischemic or thromboembolic events within 6 weeks of study surgery; Excluded at the discretion of the surgeon based upon surgical safety precautions; Known allergy/anaphylaxis to prothrombin complex concentrate or albumin; Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation; 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.