Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomisedtrial

Article


Green, L., Daru, J., Dodds, J., Jose Gonzalez Carreras, F., Lanz, D., Zamora, J., del Carmen Pardo Llorente, M., Pérez Pérez, T., Sweeney, L., Thangaratinam, S., Thomas, A. and Khan, K. S. 2020. Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomisedtrial. BMJ Open. 10 (Art. e036416).
AuthorsGreen, L., Daru, J., Dodds, J., Jose Gonzalez Carreras, F., Lanz, D., Zamora, J., del Carmen Pardo Llorente, M., Pérez Pérez, T., Sweeney, L., Thangaratinam, S., Thomas, A. and Khan, K. S.
Abstract

Introduction The incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.

Methods ACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.

We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.

The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.

JournalBMJ Open
Journal citation10 (Art. e036416)
ISSN2044-6055
Year2020
PublisherBMJ Publishing Group
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License
File Access Level
Anyone
Digital Object Identifier (DOI)doi:10.1136/bmjopen-2019-036416
Web address (URL)http://dx.doi.org/10.1136/bmjopen-2019-036416
Publication dates
Online21 Jun 2020
Publication process dates
Accepted20 May 2020
Deposited02 Jul 2020
FunderBarts Charity
Copyright holder© 2020 The Authors
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