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

Launched by KATHIRVEL SUBRAMANIAM · Nov 9, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called Kcentra compared to standard blood transfusions in patients undergoing heart transplantation surgery. The goal is to see which option works better for managing blood clotting during and after the surgery. In this trial, half of the participants will receive Kcentra, while the other half will receive fresh frozen plasma, which is a common type of blood product.

To participate in the trial, patients need to be at least 18 years old and willing to give their written consent. They must be undergoing heart transplant surgery and have been on a blood-thinning medication called warfarin for a certain period before the procedure. However, some patients may not be eligible, such as those with specific blood clotting disorders or those who have been treated with certain other medications shortly before the surgery. Participants can expect to be closely monitored during the study to ensure their safety and to gather information on how well each treatment works. This trial is currently recruiting patients, and it’s important to discuss any questions or concerns with the healthcare team.

Gender

ALL

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