The administration of fibrinogen concentrate (a component of blood involved in clotting process) to be given to those women who, after delivery of babies, develop severe bleeding to establish if this drug will prevent further blood loss or reduce the volume of blood loss.

The effect of Upfront Administration of Fibrinogen concentrate on total blood volume loss in Obstetric Haemorrhage – A Pilot study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000691640

Acronym

FIB-UPFRONT PPH

Enrollment

245

Registered

2014-07-01

Start date

2014-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Severe bleeding after delivery is a worldwide cause of mothers dying during childbirth. We can identify some of those woman at risk but in most cases there is no indication that a woman may bleed. We suspect in those cases the severe bleeding that develop is due to a low level of a clotting factor called Fibrinogen in their blood. Studies have demonstrated that there is a link between low level of fibrinogen (that helps blood clot) and those woman that have severe bleeding after delivery. We hope that to correct the level of fibrinogen will prevent severe bleeding.

Interventions

A single dose of Fibrinogen concentrate 4g given intra-venously upfront in women after delivery with a post partum blood loss of more than 1000mls and with signs of ongoing bleeding.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Insure both criteria 1) and 2) are satisfied; 1. Women with estimated blood loss greater than 1000mL in the immediate postpartum period (<4 hours postpartum). 2. Women with persistent PPH not responding to first line uterotonic therapy (i.e. syntocinon infusion), and manual uterine compression in whom further haemostatic intervention is being considered.

Exclusion criteria

Exclusion criteria 1)Women with coagulopathic disorder secondary to pre-existing liver disease. 2)Women with confirmed venous thromboembolism occurring in the last 4 weeks of pregnancy 3)Women with confirmed allergy to fibrinogen concentrate 4)Woman who refuse blood products

Outcome results