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

Kathirvel Subramaniam

Status and phase: Enrolling; Phase 3

Conditions: Heart Failure，Congestive; Heart Disease End Stage

Treatments: Drug: Frozen Plasma Product, Human; Drug: Kcentra

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03341156

STUDY19020099

Details and patient eligibility

About

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.

Full 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 patients meeting the inclusion and exclusion criteria before the initiation of any study specific procedures. Eligible patients will be randomized to receive either PCC or plasma transfusion. The efficacy of interventions will be evaluated after 30 minutes of protamine administration. After the heart transplantation, thrombocytopenia and/or hypofibrinogenemia may worsen bleeding associated with vitamin K dependent factor deficiencies. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count <100 x 103/µl, and fibrinogen <200 mg/dl, respectively. Laboratory tests (hematocrit, platelet count, PT, PTT, POC-PT, coagulation factor and inhibitor levels (e.g., factor II, antithrombin), thromboelastometry or thromboelastography, endogenous thrombin generation) will also be obtained at baseline, twice during surgery and at 12-24 hours after surgery.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Kcentra (PCC)

Experimental group

Description:

Half of subjects enrolled will be randomized to the Kcentra (PCC) group.

Treatment:

Drug: Kcentra

Frozen Plasma Product, Human

Active Comparator group

Description:

Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively.

Treatment:

Drug: Frozen Plasma Product, Human