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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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)
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.
University of Maryland
Baltimore, Maryland, United States
Upmc Presbyterian Montefiore Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States
Amount of Chest Tube Drainage
Primary outcome: Amount of chest tube output in the first 24 hours
Time frame: From patient out of room time until 24 hours after
Postoperative INR
INR value
Time frame: 30 Minutes post-treatment (after the last dose is completed)
Blood Product Use
Total hemostatic blood product use including plasma, platelets, cryoprecipitate, and recombinant activated factor VII.
Time frame: In OR (from OR entry to OR out of room time); postoperatively (patient out of room time) to 24 hours after; from 24 hours after until 30 days post surgery or until discharge (whichever comes first)
Red Blood Cell Use
Red Blood Cell Use Intraoperatively and Postoperatively
Time frame: Intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & Postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days)
Need for circulatory support
Percentage of patients who needed circulatory support (ECMO or VAD)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Mechanical Ventilation
Percentage of patients who needed mechanical ventilation for more than 72 hours
Time frame: 30 days post-operative or until discharge (whichever comes first)
Tracheostomy
Percentage of patients who needed a tracheostomy
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Time frame: 30 days post-operative or until discharge (whichever comes first)
Renal Failure
Percentage of patients who experience renal failure requiring dialysis
Time frame: 30 days post-operative or until discharge (whichever comes first)
Sepsis
Percentage of patients who experienced sepsis infection morbidity consisted of sepsis syndrome, septic shock, or mediastinitis. In addition, the diagnosis of sepsis included organisms isolated from the cultures along with elevated temperature and white blood cell counts.
Time frame: 30 days post-operative or until discharge (whichever comes first)
Death
Percentage of patients who died
Time frame: 30 days post-operative or until discharge (whichever comes first)
Stroke or postoperative neurological dysfunction
Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Gastrointestinal complication requiring bowel resection
Percentage of patients who experienced gastrointestinal complications requiring bowel resection
Time frame: 30 days post-operative or until discharge (whichever comes first)
Peripheral vascular complication
Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Deep Vein Thrombosis and Pulmonary Thromboembolism
Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism
Time frame: 30 days post-operative or until discharge (whichever comes first)
Plasma Coagulation Factor levels
Plasma coagulator factor levels will be analyzed via blood laboratory tests
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Thrombin Generation Assay
Thrombin Generation assay will be analyzed via blood laboratory tests
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Surgical Re-exploration
Surgical Re-Exploration that is related to heart transplant surgery
Time frame: 30 days post-operative or until discharge (whichever comes first)