随机对照试验比较术中细胞回收和自体输血与标准治疗治疗髋部骨折:WHITE 9 研究方案。
Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study.
机构信息
Warwick Medical School, University of Warwick, Coventry, UK.
Bone and Joint Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
出版信息
BMJ Open. 2022 Jun 8;12(6):e062338. doi: 10.1136/bmjopen-2022-062338.
INTRODUCTION
People who sustain a hip fracture are typically elderly, frail and require urgent surgery. Hip fracture and the urgent surgery is associated with acute blood loss, compounding patients' pre-existing comorbidities including anaemia. Approximately 30% of patients require a donor blood transfusion in the perioperative period. Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay. Furthermore, there is a substantial cost associated with the use of donor blood. Cell salvage and autotransfusion is a technique that recovers, washes and transfuses blood lost during surgery back to the patient. The objective of this study is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared with standard care, in improving health related quality-of-life of patients undergoing hip fracture surgery.
METHODS AND ANALYSIS
Multicentre, parallel group, two-arm, randomised controlled trial. Patients aged 60 years and older with a hip fracture treated with surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either undergo cell salvage and autotransfusion or they will follow the standard care pathway. Otherwise, all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: EuroQol-5D-5L HRQoL at 4 months post injury. Secondary outcomes will include complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use.
ETHICS AND DISSEMINATION
NHS ethical approval was provided on 14 August 2019 (19/WA/0197) and the trial registered (ISRCTN15945622). After the conclusion of this trial, a manuscript will be prepared for peer-review publication. Results will be disseminated in lay form to participants and the public.
TRIAL REGISTRATION NUMBER
ISRCTN15945622.
简介
髋部骨折患者通常为老年人,身体虚弱,需要紧急手术。髋部骨折和紧急手术会导致急性失血,使患者先前存在的合并症(包括贫血)更加复杂。大约 30%的患者在围手术期需要接受异体输血。异体输血会增加感染、过敏反应的发生率,并延长住院时间。此外,异体输血还会带来大量的成本。术中血液回收和自体输血是一种技术,可回收、清洗并将手术过程中丢失的血液回输给患者。本研究的目的是确定术中血液回收与标准护理相比,在改善髋部骨折手术患者的健康相关生活质量方面的临床和成本效益。
方法和分析
多中心、平行组、双臂、随机对照试验。年龄在 60 岁及以上、接受手术治疗的髋部骨折患者符合入组条件。参与者将按照 1:1 的比例随机分配到接受血液回收和自体输血组或接受标准护理组。否则,所有护理都将符合国家卫生与保健卓越研究所的指导原则。预计将招募至少 1128 名患者,以获得 90%的效力来检测主要终点:受伤后 4 个月时的 EuroQol-5D-5L HRQoL 差异为 0.075 分。次要结局包括并发症、术后谵妄、居住状态、活动能力、异体血使用、死亡率和资源使用。
伦理和传播
NHS 于 2019 年 8 月 14 日提供了伦理批准(19/WA/0197),并进行了试验注册(ISRCTN15945622)。在该试验结束后,将准备一份手稿进行同行评审发表。结果将以通俗易懂的形式向参与者和公众传播。
试验注册号
ISRCTN15945622。