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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

1. Informed consent from participant.

2. Women who develop PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum.

3. Age ≥ 18 years.

4. If vaginal birth: indication of one of the following procedures at the operation theatre with anaesthetic assistance: a) Estimated blood loss ≥ 500 ml and indication of manual removal of placenta or b) Indication of manual exploration of the uterus due to continuous bleeding after the birth of placenta.

5. If birth by Caesarean section: A perioperative blood loss ≥ 1000 ml.

Exclusion Criteria:

1. Patients with known inherited deficiencies of coagulation.

2. Patients in anti-thrombotic treatment prepartum due to increased risk of thrombosis.

3. Patients with a pre-pregnancy weight <45 kg.

4. Patients who refuse to receive blood transfusion.