The Transfusion Alternatives Preoperatively in Sickle Cell Disease (TAPS) study: a randomised, controlled, multicentre clinical trial

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• 作者：Dr Jo Howard ; FRCPath^a ; ^{jo.howard@gstt.nhs.uk} ; Moira Malfroy ; BA^b ; Charlotte Llewelyn ; PhD^b ; Louise Choo ; PhD^c ; Renate Hodge ; MSc^b ; Tony Johnson ; PhD^c ; Shilpi Purohit ; BSc^b ; David C Rees ; FRCP^d ; Louise Tillyer ; FRCP^e ; Isabeau Walker ; FRCA^f ; ^g ; Karin Fijnvandraat ; PhD^h ; Melanie Kirby-Allen ; MDⁱ ; Eldon Spackman ; PhD^j ; Prof Dame Sally C Davies ; FRCP^k ; Lorna M Williamson ; FRCPath^b
• 刊名：The Lancet
• 出版年：2013
• 出版时间：16-22 March, 2013
• 年：2013
• 卷：381
• 期：9870
• 页码：930-938
• 全文大小：172 K

文摘

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Summary

Background

No consensus exists on whether preoperative blood transfusions are beneficial in patients with sickle-cell disease. We assessed whether perioperative complication rates would be altered by preoperative transfusion.

Methods

We did a multicentre, randomised trial. Eligible patients were aged at least 1 year, had haemoglobin SS or S¦Â⁰thalassaemia sickle-cell-disease subtypes, and were scheduled for low-risk or medium-risk operations. Patients were randomly assigned no transfusion or transfusion no more than 10 days before surgery. The primary outcome was the proportion of clinically important complications between randomisation and 30 days after surgery. Analysis was by intention to treat.

Findings

67 (96 % ) of 70 enrolled patients¡ª33 no preoperative transfusion and 34 preoperative transfusion¡ªwere assessed. 65 (97 % ) of 67 patients had the haemoglobin SS subtype and 54 (81 % ) were scheduled to undergo medium-risk surgery. 13 (39 % ) of 33 patients in the no-preoperative-transfusion group had clinically important complications, compared with five (15 % ) in the preoperative-transfusion group (p=0¡¤023). Of these, 10 (30 % ) and one (3 % ), respectively, had serious adverse events. The unadjusted odds ratio of clinically important complications was 3¡¤8 (95 % CI 1¡¤2-12¡¤2, p=0¡¤027). 10 (91 % ) of 11 serious adverse events were acute chest syndrome (nine in the no-preoperative-transfusion group and one in the preoperative-transfusion group). Duration of hospital stay and readmission rates did not differ between study groups.

Interpretation

Preoperative transfusion was associated with decreased perioperative complications in patients with sickle-cell disease in this trial. This approach could, therefore, be beneficial for patients with the haemoglobin SS subtype who are scheduled to undergo low-risk and medium-risk surgeries.

Funding

NHS Blood and Transplant.