Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in reducing perioperative blood loss in cardiac surgery: study protocol for a non-inferiority, randomised controlled trial.

ABSTRACT:

Objective

To explore whether prothrombin complex concentrate (PCC) is not inferior to fresh frozen plasma (FFP) with regard to reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB).

Setting

Fu Wai Hospital, and Peking Union Medical College Hospital in China.

Participants

Patients undergoing elective coronary artery bypass grafting, valve replacement or valvuloplasty under CPB, between 18 and 80 years old, will be included.

Design

This study is a non-inferiority, randomised controlled clinical trial. A total of 594 subjects will be randomly assigned to two groups (group PCC and group FFP) and given corresponding interventions when at least one of the following criteria is met: (1) international normalised rat

SUBMITTER: Pei L 

PROVIDER: S-EPMC8845189 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature