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

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, during surgery and at 24 hours after surgery.

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.