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
Duration of Study in the UK
2 years, 11 months, 30 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. \n\nThe aim of this pilot trial is to gather preliminary information of the intervention and the feasibility of conducting a full scale trial. \n\nThe study will be conducted across 4 UK sites. We aim to recruit 200 women.\n\nHospitals 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. \n\nThe 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. \n\nPregnant women who are > 20 weeks gestation who are actively bleeding up to 24 hours after childbirth are eligible. \n\nWe propose to waive consent for administering intervention, and for collecting anonymised, routine baseline and clinical outcome data from all women who fulfil study criteria up to hospital discharge. \n\nHowever, consent will be obtained for a) collection of outcome data at three months; b) quality of life questionnaire; c) performing qualitative interviews, and d) collection of residual blood samples from the hospital laboratories. Consent will be obtained outside of the emergency setting and prior to discharge. \n\nData will be collected up to 3 months following the intervention and the study duration will be for 15 months.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
18/LO/1609
Date of REC Opinion
10 Oct 2018
REC opinion
Unfavourable Opinion