Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy.

ABSTRACT:

Background

Single-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery.

Methods

Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication.

Results

519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). M

SUBMITTER: Rahe-Meyer N 

PROVIDER: S-EPMC4913420 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature