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Surgical Blood Loss

Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
NCT01475669 | PHASE 3 | INTERVENTIONAL

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.

Trial Information
35 Sites
152 Participants
Recruiting
18 Years to 65 Years

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Allgemeines Krankenhaus der Stadt Wien Universittskliniken
Vienna,Austria,A-1090
Fundacao Universitaria de Cardiologia Instituto de Cardiol
Porto Alegre,Rio Grande do Sul,Brazil,90620001
InCor
Sao Paulo,Brazil,05403-000
Providence HealthSt Paul's Hospital
Vancouver,British Columbia,Canada,V6Z1Y6
Hamilton Health Science
Hamilton,Ontario,Canada,L8L2X2
Ottawa General Hospital
Ottawa,Ontario,Canada,K1H8L6
University of Toronto St. Michael's Hospital
Toronto,Ontario,Canada,M5B1W8
Toronto General Hospital
Toronto,Ontario,Canada,M5G2C4
Universite Laval Cardiologie et de Pneumologie de Quebec
Sainte Foy,Quebec,Canada,G1V4G5
University Hospital St. Anna Brno
Brno,Czech Republic,65691
Fakultni nemocnice Ostrava
Ostrava - Poruba,Czech Republic,70852
Kobenhavns UniversitetDet Sundhedsvidenskabelige Fakultet
Copenhagen,Denmark,2200
HUCH Anaestesia and Surgery
Helsinki,Finland,FI-00290
Klinikum der Universitt Mnchen
Munich,Bayern,Germany,81377
Klinikum der J.W.GoetheUniversitt
Frankfurt am Main,Hessen,Germany,60590
Study Site
Bielefeld/Hannover,Germany
Policlinico S. Orsola Malpighi
Bologna,Italy
Fondazione Centro San Raffaele
Milano,Italy,20132
Azienda Ospedaliera di Udine
Udine,Italy,33100
Nagoya University Hospital
Nagoya,Aichi,Japan,466-8560
Kurume University Hospital
Kurume,Fukuoka-ken,Japan,830-0011
Hamamatsu University Hospital
Hamamatsu,Higashi-ku,Japan,431-3192
Kobe University Hospital
Kobe,Hyogo,Japan,650-0017
Kyoto University Hospital
Kyoto,Kamigyo-ku,Japan,602-8566
Tohoku University Hospital
Sendai,Miyagi,Japan,980-8574
Tenri Hospital
Tenri,Nara,Japan,632-8552
National Cerebral and Cardiovascular Center
Suita, Osaka,Osaka,Japan,565-8565
Keio University Hospital
Shinjuku,Japan,160-8582
Inst. Kardiologii im. Prymasa Tysiaclecia Kard. S. Wyszynskiego
Warszawa - Anin,Mazowieckie,Poland,04-628
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow,Poland,31-202
Samodzielny Publiczny Szpital Kliniczny nr
Szczecin,Poland,70-111
Papworth Hospital
Cambridge,United Kingdom,CB233RE
University Hospital of Leicester
Leicester,United Kingdom,LE39QT
Liverpool Heart and Chest Hospital
Liverpool,United Kingdom,L143PE
Southampton General Hospital
Southampton,United Kingdom,SO166YD

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov