NCT01475669 - Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery | Biotech Hunter

Enrollment

152

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

September 30, 2014

Conditions

Surgical Blood LossPostoperative Blood Loss

Interventions

BIOLOGICAL

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

BIOLOGICAL

Placebo

Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH

Trial Locations (35)

2200

Kobenhavns Universitet-Det Sundhedsvidenskabelige Fakultet, Copenhagen

20132

Fondazione Centro San Raffaele, Milan

33100

Azienda Ospedaliera di Udine, Udine

60590

Klinikum der J.-W.-Goethe-Universität, Frankfurt am Main

65691

University Hospital St. Anna Brno, Brno

81377

Klinikum der Universität München, Munich

90620001

Fundacao Universitaria de Cardiologia - Instituto de Cardiol, Porto Alegre

A-1090

Allgemeines Krankenhaus der Stadt Wien - Universitätskliniken, Vienna

05403-000

InCor, São Paulo

V6Z 1Y6

Providence Health-St Paul's Hospital, Vancouver

L8L 2X2

Hamilton Health Science, Hamilton

K1H 8L6

Ottawa General Hospital, Ottawa

M5B 1W8

University of Toronto - St. Michael's Hospital, Toronto

M5G 2C4

Toronto General Hospital, Toronto

G1V 4G5

Universite Laval - Cardiologie et de Pneumologie de Quebec, Sainte-Foy

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

FI-00290

HUCH Anaestesia and Surgery, Helsinki

Unknown

Study Site, Bielefeld/Hannover

Policlinico S. Orsola Malpighi, Bologna

466-8560

Nagoya University Hospital, Nagoya

830-0011

Kurume University Hospital, Kurume

431-3192

Hamamatsu University Hospital, Hamamatsu

650-0017

Kobe University Hospital, Kobe

602-8566

Kyoto University Hospital, Kyoto

980-8574

Tohoku University Hospital, Sendai

632-8552

Tenri Hospital, Tenri

565-8565

National Cerebral and Cardiovascular Center, Suita, Osaka

160-8582

Keio University Hospital, Shinjuku

04-628

Inst. Kardiologii im. Prymasa Tysiaclecia Kard. S. Wyszynskiego, Warszawa - Anin

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow

70-111

Samodzielny Publiczny Szpital Kliniczny nr 2, Szczecin

CB23 3RE

Papworth Hospital, Cambridge

LE3 9QT

University Hospital of Leicester, Leicester

L14 3PE

Liverpool Heart and Chest Hospital, Liverpool

SO16 6YD

Southampton General Hospital, Southampton