Administering Cryoprecipitate in Obstetric Bleeding at an Earlier Time
Research type
Research Study
Full title
The effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage: A pilot cluster randomised trial.
IRAS ID
237959
Contact name
Laura Green
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN12146519
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
ACROBAT is a pragmatic, non blinded, cluster randomised controlled feasibility study of early administration of cryoprecipitate (within 90 minutes) versus standard of care (major obstetric haemorrhage protocol) for pregnant women with postpartum haemorrhage.
The aim of this pilot trial is to gather preliminary information of the intervention and the feasibility of conducting a full scale trial.
The study will be conducted across 4 UK sites. We aim to recruit 200 women.
Hospitals will be randomised to either the intervention or control group. The intervention group will deliver cryoprecipitate within 90 minutes to any women who meet the elibility criteria. The control arm will continue to give cryoprecipitate in response to low fibrinogen level <2g/L or if they have received massive transfusion (i.e. > 8 units red blood cells). The study will be fully unblinded to participants, clinical staff and the central research team.
Pregnant women who are > 24 weeks gestation who are actively bleeding up to 24 hours after childbirth are eligible.
We propose to waive consent for administering the intervention. Women will be asked to give consent for their routine, de-identified data to be collected from medical notes, up to hospital discharge or 28 days after delivery – whichever is first.
They will also be asked to consent to the collection of non-routine data, including: three months follow-up data; the MFI questionnaire; readiness to be contacted for later qualitative interview; and collection of residual blood samples from the hospital laboratories.
However, for women who die, or are discharged from hospital before being correctly identified and approached for their consent, we propose to collect their routine, de-identified data from medical notes up to hospital discharge or 28 days after delivery – whichever is first.
Data will be collected up to 3 months following the intervention and the study duration will be for 15 months.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/2062
Date of REC Opinion
15 Jan 2019
REC opinion
Further Information Favourable Opinion