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

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Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)
PLOS Medicine ( IF 10.5 ) Pub Date : 2017-12-19 , DOI: 10.1371/journal.pmed.1002471
Khalid S Khan ₁ , Philip A S Moore ₂ , Matthew J Wilson ₃ , Richard Hooper ₄ , Shubha Allard ₅ , Ian Wrench ₆ , Lee Beresford ₄ , Tracy E Roberts ₇ , Carol McLoughlin ₇ , James Geoghegan ₂ , Jane P Daniels ₈ , Sue Catling ₉ , Vicki A Clark ₁₀ , Paul Ayuk ₁₁ , Stephen Robson ₁₂ , Fang Gao-Smith ₁₃ , Matthew Hogg ₁₄ , Doris Lanz ₁ , Julie Dodds ₁ ,

Affiliation

Women's Health Research Unit, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom.
Birmingham Women's Hospital, Birmingham, United Kingdom.
School of Health and Related Research, University of Sheffield, United Kingdom.
Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, United Kingdom.
NHS Blood and Transplant, London, United Kingdom.
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.
Health Economics Unit, Institute of Applied Health Research, University of Birmingham, United Kingdom.
Nottingham Clinical Trials Unit, University of Nottingham, United Kingdom.
Singleton Hospital, Swansea, United Kingdom.
Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Royal Victoria Infirmary, Newcastle-upon-Tyne, United Kingdom.
Institute of Cellular Medicine, Newcastle University, United Kingdom.
Peri-operative, Critical Care and Trauma Trials Group, University of Birmingham, United Kingdom.
Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.

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.

中文翻译：

剖宫产期间的细胞回收和供体输血：一项务实的多中心随机对照试验 (SALVO)

背景

剖腹产时出血过多需要输血（同种异体）。细胞回收可以减少这一要求。

方法和结果

我们进行了一项务实的随机对照试验（在 26 个产科单位；参与者于 2013 年 6 月 4 日至 2016 年 4 月 17 日招募），对剖宫产妇女中常规细胞挽救使用（干预）与目前无常规细胞挽救使用（对照）的护理标准进行比较。出血的风险。使用可变大小的随机排列块对随机化进行分层。在意向治疗分析中，我们使用多变量模型，调整分层变量和先验确定的预后因素，比较 RhD 阴性女性和 RhD 阴性女性的供血率（主要结果）和胎儿母体出血≥2 ml组间的阳性婴儿（次要结果）。在 3,028 名随机分配的女性（分析了 2,990 名）中，分配到干预组的 1,498 名女性中，95.6% 部署了细胞回收（50.8% 回收了回收的血液；平均 259.9 毫升），而分配到对照组的 1,492 名女性中，这一比例为 3.9%。对照组的献血者输血率为 3.5%，而干预组为 2.5%（调整后的比值比 [OR] 0.65，95% 置信区间 [CI] 0.42 至 1.01，p = 0.056；调整后的风险差 -1.03，95% CI -2.13 至 0.06）。在计划的亚组分析中，紧急剖宫产中分配至对照组的妇女的输血率为 4.6%，而干预组中的输血率为 3.0%（调整后 OR 0.58，95% CI 0.34 至 0.99），而选择性剖宫产中的输血率为 2.2% 对比 1.8%剖宫产（调整后 OR 0.83，95% CI 0.38 至 1.83）（交互作用p = 0.46）。未观察到羊水栓塞病例。干预后母婴出血率较高（对照组为 10.5%，干预组为 25.6%，调整后 OR 5.63，95% CI 1.43 至 22.14，p = 0.013）。我们无法评论长期抗体致敏效应。