31 research outputs found
A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial
Background
Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking.
Objectives
To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use.
Design
Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded.
Setting
A total of 26 UK obstetric units.
Participants
Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated.
Interventions
Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed.
Main outcome measures
Primary â donor blood transfusion. Secondary â units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by KleihauerâBetke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes â costs of resources and service provision taking the UK NHS perspective.
Results
We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; pâ=â0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction pâ=â0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; pâ=â0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at ÂŁ8110 per donor blood transfusion avoided.
Conclusions
The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective.
Future work
Research into risk of alloimmunisation among women exposed to cell salvage is needed.
Trial registration
Current Controlled Trials ISRCTN66118656.
Funding
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information
An assessment of the cost-effectiveness of magnetic resonance, including diffusion-weighted imaging in patients with transient ischaemic attack and minor stroke : a systematic review, meta-analysis and economic evaluation
Erratum issued September 2015 Erratum DOI: 10.3310/hta18270-c201509Peer reviewedPublisher PD
'Are you Aboriginal and/or Torres Strait Islander?': improving data collection at BreastScreen Victoria
Objective: To evaluate the ascertainment
and recording of clientsâ Indigenous status
at BreastScreen Victoria (BSV) by
assessing: staff compliance with best
practice recommendations in ascertaining
Indigenous status data collection practices;
and the consistency of recording of
Indigenous status between visits.
Methods: The Australian Bureau of
Statistics/Australian Institute of Health and
Welfare best practice recommendations for
collecting Indigenous status data were
compared against BSV practices. One
hundred and thirty-three BSV staff were
also surveyed about their practices of
ascertaining Indigenous status. An audit of
the consistency of recording Indigenous
status at first and most recent visit to BSV
was also conducted.
Results: Current ascertainment and recording of Indigenous status by BSV staff
does not comply with best practice
recommendations. A high proportion of staff
were not ascertaining Indigenous status
(34%), and/or perceived they were
prevented from asking women whether they
were Indigenous (53%). The consistency of
recording of Indigenous status between
womenâs visits was also low.
Implications: Our findings are likely to be
found in other services where collection of
Indigenous status data occurs. To improve
data collection, services need to: ensure
questions regarding Indigenous status
comply with best practice
recommendations; provide staff training
regarding the importance of collecting the
information; and improve Indigenous
participation and control of data collection
and dissemination