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Clinical trial

Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT

ID
Name
STUDY19020099
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.
Trial arms
Trial start
2018-07-11
Estimated PCD
2024-10-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Kcentra
Kcentra will be administered in 2 divided doses; Pre-bypass (5-10 units/kg based on body weight and preoperative INR and post-protamine based of the pre-bypass dose and the preoperative INR; daily maximum dose not to exceed 5000 IU (50 IU/kg)
Arms:
Kcentra (PCC)
Other names:
prothrombin complex concentrate
Frozen Plasma Product, Human
If the patient is randomized to receive standard transfusion they will receive 2 U of fresh frozen plasma intravenously before cardiopulmonary bypass and then up to 4-8 U of plasma added to the cardiopulmonary bypass reservoir during rewarming.
Arms:
Frozen Plasma Product, Human
Other names:
Fresh Frozen Plasma
Size
60
Primary endpoint
Amount of Chest Tube Drainage
From patient out of room time until 24 hours after
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-01-08

1 organization

2 products

2 indications

Organization
Kathirvel Subramaniam
Product
Kcentra
Indication
End-Stage Heart Disease
Indication
Heart Failure
Product
Frozen Plasma