Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
NCT ID: NCT01475669
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2012-01-31
2014-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fibrinogen Concentrate (Human)
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
Placebo
Placebo
Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH
Interventions
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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
Placebo
Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Niels Rahe-Meyer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Allgemeines Krankenhaus der Stadt Wien - Universitätskliniken
Vienna, , Austria
Fundacao Universitaria de Cardiologia - Instituto de Cardiol
Porto Alegre, Rio Grande do Sul, Brazil
InCor
São Paulo, São Paulo, Brazil
Providence Health-St Paul's Hospital
Vancouver, British Columbia, Canada
Hamilton Health Science
Hamilton, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
University of Toronto - St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Universite Laval - Cardiologie et de Pneumologie de Quebec
Sainte-Foy, Quebec, Canada
University Hospital St. Anna Brno
Brno, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Kobenhavns Universitet-Det Sundhedsvidenskabelige Fakultet
Copenhagen, , Denmark
HUCH Anaestesia and Surgery
Helsinki, , Finland
Klinikum der Universität München
Munich, Bavaria, Germany
Klinikum der J.-W.-Goethe-Universität
Frankfurt am Main, Hesse, Germany
Study Site
Bielefeld/Hannover, , Germany
Policlinico S. Orsola Malpighi
Bologna, , Italy
Fondazione Centro San Raffaele
Milan, , Italy
Azienda Ospedaliera di Udine
Udine, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hamamatsu University Hospital
Hamamatsu, Higashi-ku, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kyoto University Hospital
Kyoto, Kamigyo-ku, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tenri Hospital
Tenri, Nara, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Osaka, Japan
Keio University Hospital
Shinjuku, , Japan
Inst. Kardiologii im. Prymasa Tysiaclecia Kard. S. Wyszynskiego
Warszawa - Anin, Masovian Voivodeship, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2
Szczecin, , Poland
Papworth Hospital
Cambridge, , United Kingdom
University Hospital of Leicester
Leicester, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Gill R. Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery: post hoc analysis and interpretation of phase III results. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):566-574. doi: 10.1093/icvts/ivy302.
Rahe-Meyer N, Levy JH, Mazer CD, Schramko A, Klein AA, Brat R, Okita Y, Ueda Y, Schmidt DS, Ranganath R, Gill R. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy. Br J Anaesth. 2016 Jul;117(1):41-51. doi: 10.1093/bja/aew169.
Other Identifiers
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2011-002685-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BI3023_3002
Identifier Type: -
Identifier Source: org_study_id
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