Surgical Blood Loss Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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