NCT01475669

Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery

REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine. The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.

Conditions

• Surgical Blood Loss
• Postoperative Blood Loss

Interventions

Type	Name	Description
BIOLOGICAL	Fibrinogen Concentrate (Human) (FCH)	Single dose infused intravenously within 5 minutes of the completion of the measurement of the 5-minute bleeding mass; the dose is determined individually based on the measured maximum clot firmness (MCF) and subject body weight
BIOLOGICAL	Placebo	Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2011-11-21
• Last updated: 2014-09-18

Locations

35 sites across 11 countries: Austria, Brazil, Canada, Czechia, Denmark, Finland, Germany, Italy, Japan, Poland, United Kingdom