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

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.

Conditions

• Postpartum Haemorrhage

Interventions

DRUG

Fibrinogen Concentrate

2 gram intra venous

DRUG

Isotonic Saline

Isotonic saline in equivalent volume - 100 ml

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Blood Bank of the Danish capital region

  collaborator UNKNOWN

• Unit for monitoring of Good Clinical Practice Copenhagen University

  collaborator UNKNOWN

• Danish Council for Independent Research

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Laerdal Foundation

  collaborator OTHER

• Aase and Ejnar Danielsens Foundation

  collaborator OTHER

• The Foundation of 17.12.1981

  collaborator OTHER

• Fonden til Lægevidenskabens Fremme

  collaborator OTHER

• Hans og Nora Buchards Fond

  collaborator UNKNOWN

• Haemonetics Corporation

  collaborator INDUSTRY

• Copenhagen University Hospital at Herlev

  lead OTHER

Principal Investigators

• Anne J. Wikkelsoe, MD · Department of Anaesthesiology, University Hospital of Herlev, Denmark

• Ann M. Møller, MD, DmSc · Department of Anaesthesiology, University Hospital of Herlev, Denmark

• Jakob Stensballe, MD, PhD · Blood Bank of Danish Capital Region, Rigshospitalet

• Jens Langhoff-Roos, MD, DmSc · Department of Obstetrics, Juliane Marie Centre, Rigshospitalet

• Arash Afshari, MD · Department of Anaesthesiology, Juliane Marie Centre, Rigshospitalet, Denmark

• Hellen McKinnon Edwards, M.D. · Dep. of Anaesthesiology, Herlev

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2013-05-31

Completion

2013-07-31

Countries

• Denmark

Study Locations