Dataset Information

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 randomised trial.

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.

Ethics and dissemination

The trial has approvals from the London-Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.

Trial registration number

ISRCTN12146519.

SUBMITTER: Green L

PROVIDER: S-EPMC7311066 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 randomised trial.

Green Laura L Daru Jahnavi J Dodds Julie J Gonzalez Carreras Francisco Jose FJ Lanz Doris D Zamora Javier J Pardo Llorente Maria Del Carmen MDC Pérez Pérez Teresa T Sweeney Lorna L Thangaratinam Shakila S Thomas Amy A Khan Khalid Saeed KS

BMJ open 20200621 6

<h4>Introduction</h4>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 ...[more]

PMID: 32565469

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Project description:There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent, leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment was 32% (95%CI 23-41%) in the intervention group vs. 81% (95%CI 70-90%) in the control group. The proportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control (31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference -0.6 units, 95%CI -1.2 to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3-1.1); and intensive care admissions (odds ratio 0.4, 95%CI 0.1-1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation.

Project description:ObjectiveThe ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial.SettingQualitative interview study within a cluster-randomised pilot trial, involving four London maternity services.ParticipantsIndividual interviews were conducted postnatally with 10 women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four 'recruiters'-two research midwives and two clinical trials practitioners who conducted trial recruitment.ResultsConsent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data.ConclusionOur findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring-that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand.Trial registration numberISRCTN12146519.

Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Project description:ImportanceAlthough most massive transfusion protocols incorporate cryoprecipitate in the treatment of hemorrhaging injured patients, minimal data exist on its use in children, and whether its addition improves their survival is unclear.ObjectiveTo determine whether cryoprecipitate use for injured children who receive massive transfusion is associated with lower mortality.Design, setting, and participantsThis retrospective cohort study included injured patients examined between January 1, 2014, and December 31, 2017, at one of multiple centers across the US and Canada participating in the Pediatric Trauma Quality Improvement Program. Patients were aged 18 years or younger and had received massive transfusion, which was defined as at least 40 mL/kg of total blood products in the first 4 hours after emergency department arrival. Exclusion criteria included hospital transfer, arrival without signs of life, time of death or hospital discharge not recorded, and isolated head injuries. To adjust for potential confounding, a propensity score for treatment was created and inverse probability weighting was applied. The propensity score accounted for age, sex, race/ethnicity, injury type, payment type, Glasgow Coma Scale score, hypoxia, hypotension, assisted respirations, chest tube status, Injury Severity Score, total volume of blood products received, hemorrhage control procedure, hospital size, academic status, and trauma center designation. Data were analyzed from December 11, 2019, to August 31, 2020.ExposuresCryoprecipitate use within the first 4 hours of emergency department arrival.Main outcomes and measuresIn-hospital 24-hour and 7-day mortality.ResultsOf the 2387 injured patients who received massive transfusion, 1948 patients were eligible for analysis. The median age was 16 years (interquartile range, 9-17 years), 1382 patients (70.9%) were male, and 807 (41.4%) were White. A total of 541 patients (27.8%) received cryoprecipitate. After propensity score weighting, patients who received cryoprecipitate had a significantly lower 24-hour mortality when compared with those who did not (adjusted difference, -6.9%; 95% CI, -10.6% to -3.2%). Moreover, cryoprecipitate use was associated with a significantly lower 7-day mortality but only in children with penetrating trauma (adjusted difference, -9.2%; 95% CI, -15.4% to -3.0%) and those transfused at least 100 mL/kg of total blood products (adjusted difference, -7.7%; 95% CI, -15.0% to -0.5%).Conclusions and relevanceIn this cohort study, early use of cryoprecipitate was associated with lower 24-hour mortality among injured children who required massive transfusion. The benefit of cryoprecipitate appeared to persist for 7 days only in those with penetrating trauma and in those who received extremely large-volume transfusion.

Project description:ObjectivesTo estimate the incidence of, and investigate risk factors for, postpartum haemorrhage (PPH) requiring transfer to obstetric care following birth in midwifery units (MU) in the UK; to describe outcomes for women who experience PPH requiring transfer to obstetric care.MethodsWe conducted a national population-based case-control study in all MUs in the UK using the UK Midwifery Study System (UKMidSS). Between September 2019 and February 2020, 1501 women with PPH requiring transfer to obstetric care following birth in an MU, and 1475 control women were identified. We used multivariable logistic regression, generating adjusted odds ratios (aORs) and 95% confidence intervals (CIs) to investigate risk factors for PPH requiring transfer to obstetric care.ResultsThe incidence of PPH requiring transfer to obstetric care following birth in an MU was 3.7% (95% CI 3.6%-3.9%). Factors independently associated with PPH requiring transfer to obstetric care were smoking during pregnancy (aOR = 0.73; 95% CI 0.56-0.94), nulliparity (aOR = 1.96; 95% CI 1.66-2.30), previous PPH (aOR = 2.67; 95% CI 1.67-4.25), complications in a previous pregnancy other than PPH (aOR = 2.40; 95% CI 1.25-4.60), gestational age ≥41 weeks (aOR = 1.36; 95% CI 1.10-1.69), instrumental birth (aOR = 2.69; 95% CI 1.53-4.72), third stage of labour ≥60 minutes (aOR = 5.56; 95% CI 3.93-7.88), perineal trauma (aOR = 4.67; 95% CI 3.16-6.90), and birthweight 3500-3999g (aOR = 1.71; 95% CI 1.42-2.07) or ≥4000g (aOR = 2.31; 95% CI 1.78-3.00). One in ten (10.6%) cases received a blood transfusion and one in five (21.0%) were admitted to higher level care.ConclusionsThe risk factors identified in this study align with those identified in previous research and with current guidelines for women planning birth in an MU in the UK. Maternal outcomes after PPH were broadly reassuring and indicative of appropriate management. NHS organisations should ensure that robust guidelines are in place to support management of PPH in MUs.

Dataset Information

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 randomised trial.

Introduction

Methods

Ethics and dissemination

Trial registration number

Publications

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 randomised trial.

Similar Datasets

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