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.

35 Sites

152 Participants

Recruiting

18 Years to 55 Years

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SUBMIT

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

Inclusion Criteria

At Screening:
* Undergoing elective open surgical procedures on any part of the aorta requiring cardiopulmonary bypass (CPB), with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
* 18 years of age or older.
* Written informed consent for study participation obtained before undergoing any study specific procedures.
Intraoperative (at the 1st 5-minute bleeding mass):
* A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
* Minimum core body temperature 35°C, measured according to local practice.
* Activated clotting time ± 25% of baseline levels.
* Blood pH \> 7.3.

Exclusion Criteria

At Screening and/or baseline:
* Undergoing emergency aortic repair surgery.
* Reoperative aortic surgery at the same anatomic site as the original procedure such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
* Any operation for infection.
* Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand's disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
* Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
* Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery.
* Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the 48 hours preceding study surgery.
* Factor Xa inhibitors within 2 days preceding study surgery.
* IIb/IIIa antagonist administration in the 24 hours preceding study surgery.
* Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others.
* An international normalized ratio \> 1.3 immediately preceding the start of surgery.
Intraoperative (at the 1st 5-minute bleeding mass):
* Use of any systemic hemostatic therapy (such as FFP, platelets, prothrombin complex concentrates) from the beginning of surgery until IMP administration.

Additional Studies

Additional studies can be found at ClinicalTrials.gov