Department of Orthopaedics, Peking University Third Hospital, Beijing, China.
Engineering Research Center of Bone and Joint Precision Medicine, Ministry of Education, Beijing, People's Republic of China.
BMJ Open. 2022 Feb 15;12(2):e053846. doi: 10.1136/bmjopen-2021-053846.
Preoperative autologous blood donation (PABD) can be used to reduce the exposure of allogeneic blood transfusion in patients undergoing elective surgery. Better blood management to avoid anaemia and reduce allogeneic blood transfusion after spine surgery become increasingly important with development of enhanced recovery after surgery. We present here the design of a randomised controlled trial with three groups to verify the clinical effectiveness of PABD in patients at high risk of transfusion for lumbar fusion surgery and explore the optimal timing of autologous blood donation.
Patients (age 18-70 years) who will receive lumbar fusion surgery for degenerative disease with haemoglobin over 110 g/L and 'high risk' of allogeneic blood transfusion are eligible, unless they refuse participation or are diagnosed with malignant metastases, infection, cardiovascular and cerebrovascular diseases, haematological disorders or relevant drug history and critical illnesses. A total of 1200 patients will be recruited and randomised into three groups. Patients in group A will not receive PABD and be regarded as control group. PABD will be performed for patients in groups B and C. Blood donation will be finished at 1 week (±3 day) before surgery in group B and 2 weeks (±3 day) before surgery in group C. Primary outcome measures will include haemoglobin decline, incidence and amount of allogeneic blood transfusion. Secondary outcome measures will include days of hospitalisation after surgery, haematocrit level and incidence of complications. This study is a single-centre and open-label randomised controlled trial. The sample size is calculated with reference to the retrospective data and previous studies.
This trial has been approved by the Peking University Third Hospital Medical Science Research Ethic Committee (no: 2020-262-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.
ChiCTR2000039824, preresults.
术前自体输血（PABD）可用于减少择期手术患者的异体输血。随着手术后加速康复的发展，更好的血液管理以避免贫血并减少脊柱手术后的异体输血变得越来越重要。我们在此介绍了一项随机对照试验的设计，该试验分为三组，以验证 PABD 在接受腰椎融合术的高输血风险患者中的临床效果，并探索自体采血的最佳时机。
符合条件的患者（年龄 18-70 岁）将接受腰椎融合术治疗退行性疾病，血红蛋白水平>110g/L，且“高风险”需要异体输血，除非他们拒绝参与或被诊断为恶性转移、感染、心血管和脑血管疾病、血液系统疾病或相关药物史和危重病。总共将招募 1200 名患者并随机分为三组。组 A 的患者将不接受 PABD，作为对照组。组 B 和组 C 的患者将进行 PABD。组 B 的采血将在手术前 1 周（±3 天）完成，组 C 的采血将在手术前 2 周（±3 天）完成。主要观察指标包括血红蛋白下降、异体输血的发生率和数量。次要观察指标包括术后住院天数、血细胞比容水平和并发症发生率。本研究为单中心、开放标签的随机对照试验。样本量的计算参考了回顾性数据和以往的研究。
本试验已获得北京大学第三医院医学科学研究伦理委员会的批准（编号：2020-262-02）。试验结果将提交给同行评议的期刊发表，并作为会议报告。
ChiCTR2000039824，预注册。
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