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

PHASE3TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

July 11, 2018

Primary Completion Date

September 18, 2020

Study Completion Date

February 20, 2025

Conditions
Heart Disease End StageHeart Failure,Congestive
Interventions
DRUG

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)

DRUG

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.

Trial Locations (3)

15213

Upmc Presbyterian Montefiore Hospital, Pittsburgh

UPMC Presbyterian Shadyside, Pittsburgh

21201

University of Maryland, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CSL Behring

INDUSTRY

lead

University of Maryland, Baltimore

OTHER