Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

July 31, 2013

Conditions
Postpartum Haemorrhage
Interventions
DRUG

Fibrinogen Concentrate

2 gram intra venous

DRUG

Isotonic Saline

Isotonic saline in equivalent volume - 100 ml

Trial Locations (4)

2100

Juliane Marie Centre, Rigshospitalet, Copenhagen

2650

University Hospital of Hvidovre, Hvidovre

2730

University Hospital of Herlev, Herlev

3400

University Hospital of Hilleroed, Hilleroed

All Listed Sponsors
collaborator

Rigshospitalet, Denmark

OTHER

collaborator

Copenhagen University Hospital, Hvidovre

OTHER

collaborator

Hillerod Hospital, Denmark

OTHER

collaborator

Blood Bank of the Danish capital region

UNKNOWN

collaborator

Unit for monitoring of Good Clinical Practice Copenhagen University

UNKNOWN

collaborator

Danish Council for Independent Research

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Laerdal Foundation

OTHER

collaborator

Aase and Ejnar Danielsens Foundation

OTHER

collaborator

The Foundation of 17.12.1981

OTHER

collaborator

Fonden til Lægevidenskabens Fremme

OTHER

collaborator

Hans og Nora Buchards Fond

UNKNOWN

collaborator

Haemonetics Corporation

INDUSTRY

lead

Copenhagen University Hospital at Herlev

OTHER