Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths
worldwide each year. The investigators aim to investigate if early treatment with fibrinogen
concentrate versus saline can reduce the incidence of blood transfusion in women with
postpartum haemorrhage.
A low level of fibrinogen has been associated with increased blood loss and transfusion
requirements in different clinical settings including obstetrical bleeding. Early up-front
treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic
capacity in women with postpartum haemorrhage.
The investigators plan to enrol 245 patients on four hospitals in the Capital Region of
Denmark during a two year period.
As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as
haemostatic monitoring of all participants during the trial: Baseline test is taken at
inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken
immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the
providers of treatment - the rest is clinically available.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Copenhagen University Hospital at Herlev
Collaborators:
Aase and Ejnar Danielsens Foundation Blood Bank of the Danish capital region Copenhagen University Hospital, Hvidovre Danish Council for Independent Research Fonden til Lægevidenskabens Fremme Haemonetics Corporation Hans og Nora Buchards Fond Herlev Hospital Hillerod Hospital, Denmark Laerdal Acute Foundation Laerdal Foundation Rigshospitalet, Denmark The Foundation of 17.12.1981 Unit for monitoring of Good Clinical Practice Copenhagen University