複雑な心血管手術中の出血を制御するためのヒトフィブリノゲン濃縮製剤（FCH）の研究

基本情報

NCT ID

NCT01475669

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

152

治験依頼者名

CSL Behring

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (9)