Collins 2013.

Trial name or title	Fibrinogen concentrate to treat postpartum haemorrhage – OBS2 Study
Methods	A multicentre, prospective, double blind randomised control trial
Participants	Women experiencing major postpartum haemorrhage (PPH). About 1050 women will be recruited into the observational phase of the study so that 60 can be randomised to receive fibrinogen concentrate or placebo.
Interventions	Fibrinogen concentrate (RiaStap®) versus placebo. The woman will receive a bolus infusion of either fibrinogen concentrate or placebo plus standard treatment. The dose of fibrinogen concentrate or placebo to be infused will be calculated based on the woman's ideal body weight for height and the measured FIBTEM A5 with the aim of increasing the FIBTEM A5 to 23 mm.
Outcomes	Primary endpoints: The total number of allogeneic blood products transfused after study medication until discharge. The total number of allogeneic blood products transfused will be compared between the two arms.
Starting date	May 2013
Contact information	Dr P Collins, Reader in Haematology, Dept of Haematology, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN Tel : 02920744144 E‐mail :peter.collins@wales.nhs.uk
Notes	Estimated end: September 2014