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Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO)

Khan, Khalid S.; Moore, Philip A.S.; Wilson, Matthew J.; Hooper, Richard; Allard, Shubha; Wrench, Ian; Beresford, Lee; Roberts, Tracy E.; McLoughlin, Carol; Geoghegan, James; Daniels, Jane P.; Catling, Sue; Clark, Vicki A.; Ayuk, Paul; Robson, Stephen; Gao-Smith, Fang; Hogg, Matthew; Lanz, Doris; Dodds, Julie

Authors

Khalid S. Khan

Philip A.S. Moore

Matthew J. Wilson

Richard Hooper

Shubha Allard

Ian Wrench

Lee Beresford

Tracy E. Roberts

Carol McLoughlin

James Geoghegan

Jane P. Daniels

Sue Catling

Vicki A. Clark

Paul Ayuk

Stephen Robson

Fang Gao-Smith

Matthew Hogg

Doris Lanz

Julie Dodds



Abstract

Background: Excessive haemorrhage at caesarean section requires donor (allogeneic) blood transfusion. Cell 34 salvage may reduce this requirement.
Methods and findings: We conducted a pragmatic randomised controlled trial (26 obstetric units; June 2013 through April 2016) of routine cell salvage use (intervention) vs. current standard of care without routine salvage use (control) in caesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2ml in RhD-negative women with RhD-positive baby (a secondary outcome) between groups.
Among 3028 women randomised (2990 analysed), 95.6% of 1498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) vs. 3.9% of 1492 assigned to control. Donor blood transfusion rates were 3.5% in the control group vs. 2.5% in intervention (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p=0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06; number needed to treat [NNT] 97, at the lower limit of 95% confidence NNT was 47 and at the upper limit the number needed to harm was 1,667). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control vs. 3.0% in the intervention group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% vs. 1.8% among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p=0.46). No case of amniotic fluid embolism was observed. Fetomaternal haemorrhage was higher with intervention (10.5% in control vs. 25.6% in intervention, adjusted OR 5.63, 95% CI 1.43 to 22.14, p=0.013). We are unable to comment on long-term antibody sensitisation effects.
Conclusions: The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during caesarean section was not statistically significant.

Journal Article Type Article
Publication Date Dec 19, 2017
Journal PLoS Medicine
Electronic ISSN 1549-1277
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 14
Issue 12
Article Number e1002471
APA6 Citation Khan, K. S., Moore, P. A., Wilson, M. J., Hooper, R., Allard, S., Wrench, I., …Dodds, J. (2017). Cell salvage and donor blood transfusion during Caesarean section: a pragmatic multicentre randomised controlled trial (SALVO). PLoS Medicine, 14(12), doi:10.1371/journal.pmed.1002471. ISSN 1549-1277
DOI https://doi.org/10.1371/journal.pmed.1002471
Keywords Intraoperative Blood Cell Salvage, Caesarean Section, Obstetrics
Publisher URL http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002471
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
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