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OBS2

Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: a multicentre, prospective, double blind randomised control trial

Background and study aims

Bleeding at the time of childbirth (postpartum haemorrhage, PPH) is a major cause of death. Bleeding is caused when the uterus fails to contract or by operations. This is made worse by damage of blood clotting system. A number of studies have shown that low levels

of a blood clotting factor called fibrinogen is associated with worse bleeding, the need for surgical measures and the need for blood transfusion. This study will investigate whether infusion of fibrinogen concentrate, based on the FIBTEM A5 test, during a moderately severe PPH reduces the total number of allogeneic blood products transfused after study medication until discharge compared to placebo.

Who can participate?

Women experiencing major postpartum haemorrhage (PPH) can participate in this study.

What does the study involve?

Participating women are randomly allocated to one of two groups. One group will receive fibrinogen concentrate injected into the vein and the other group will receive a placebo (dummy). All participants will be contacted via telephone after 6 weeks by a midwife.

What are the possible benefits and risks of participating?

We hope that giving fibrinogen will reduce blood loss, so there may be a benefit to the participant from taking part in this study. We hope that the results may help to improve the treatment of women who experience similar blood loss at the time of childbirth in the future. Fibrinogen is not a new treatment and it has been used in patients who have low levels of fibrinogen for many years, but its use in bleeding at the time of childbirth is relatively new. There is no evidence to suggest that fibrinogen has any serious side effects when used during childbirth but, because it is not routinely used at this time, we may not know all the possible side effects. The idea of giving women fibrinogen is to thicken the blood to stop bleeding but it is possible that this may cause clots where they are not needed and we will be especially looking for this.

Where is the study run from?

The study will be run from four centres in the UK: Cardiff and Vale University Health Board, Leicester Royal Infirmary, University College Hospital London and Liverpool Women’s Hospital NHS Foundation Trust.

When is the study starting and how long is it expected to run for?

Recruitment starts in June 2013 and will end in December 2014. Participating women will be followed up for 6 weeks.

Who is funding the study?

CSL Behring

SEWTU Role

Full coordination

Study Type

Randomised Control Trial

Status

Open

Funder

CSL Behring

SEWTU Value

£492,449

Lead Investigator

Dr Peter Collins

Study Team

Julia Townson (Senior Trial Manager)

Dr Nadine Aawar (Trial Manager)

Dr Rebecca Cannings-John (Statistician)

Mrs Judith Evans (Research Administrator)

Mr Vincent Poile (Database Programmer)

Contact information

Email address
AawarN@cardiff.ac.uk
Telephone
+44 29 20687146, ext. 87146 (Office)

Key data

Status
Running
Start date
Oct. 1, 2012
End date
Dec. 30, 2014
Grant value
£718,871
General enquiries
Dr Nadine Aawar

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