Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)

BACKGROUND: Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. METHODS AND FINDINGS: We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean 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 ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (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). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, 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 cesarean section was not statistically significant. TRIAL REGISTRATION: This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656

Evaluation of blood reservation and use for caesarean sections in a tertiary maternity unit in south western Nigeria

<p>Abstract</p> <p>Background</p> <p>Haemorrhage from obstetric causes is the most common cause of maternal mortality in the developing world. Prevention of mortality from haemorrhage will necessarily involve prompt blood transfusions among other life saving measures. There are however limited stocks of fresh or stored blood in many health care facilities in Sub Saharan Africa. Caesarean section has been identified as a common indication for blood transfusion in obstetrics practice and its performance is often delayed by non availability of blood in our centre. An evaluation of blood reservation and use at caesarean sections in a tertiary maternity unit in Lagos, south western Nigeria should therefore assist in formulating the most rational blood transfusion policies.</p> <p>Methods</p> <p>Case records of 327 patients who had elective and emergency caesarian sections at the Lagos State University Teaching Hospital between 1^stOctober and 31^stDecember 2007 were reviewed. Data pertaining to age, parity, booking status, type and indication for Caesarean section, pre- and post-operative packed cell volume, blood loss at surgery, units of blood reserved in the blood bank, unit(s) of blood transfused and duration of hospital stay was extracted and the data analysed.</p> <p>Results</p> <p>There were 1056 deliveries out of which 327 (31%) were by Caesarean section. During the study period, a total of 654 units of blood were reserved in the blood bank and subsequently made available in theatre. Out of this number, only 89 (13.6%) were transfused to 41 patients. Amongst those transfused, twenty-six (54%) were booked and 31 (75.6%) had primary caesarian section. About 81% of those transfused had emergency caesarean section. The most common indication for surgery among those transfused were placenta praevia (9 patients with 21 units of blood) and cephalo-pelvic disproportion (8 patients with 13 units).</p> <p>Conclusion</p> <p>Even though a large number of units of blood was reserved and made available in the theatre at the time of operation, majority of the patients operated did not need blood transfusion. Provision of a mini- blood bank within the obstetric unit and careful patient categorization will ensure timely availability of blood for surgery without necessarily tying down stock in the central blood bank.</p