Akowuah Enoch, Goodwin Andrew T, Owens W Andrew, Hancock Helen C, Maier Rebecca, Kasim Adetayo, Mellor Adrian, Khan Khalid, Murphy Gavin, Mason James
Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
Durham Clinical Trials Unit, School of Medicine, Pharmacy and Health, Durham University, Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK.
Trials. 2017 Jan 28;18(1):46. doi: 10.1186/s13063-016-1768-4.
Aortic valve replacement is one of the most common cardiac surgical procedures performed worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1 cm below the manubrio-sternal junction. More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red blood cell transfusion requirements between the two techniques. Given the implications for National Health Service resources and patient outcomes, a definitive trial is needed.
METHODS/DESIGN: This is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement surgery using manubrium-limited ministernotomy (intervention) and conventional median sternotomy (usual care). Two hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss, re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care utilisation, cost and cost effectiveness and adverse events.
This is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement surgery.
International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910 . Registered on 3 February 2014.
主动脉瓣置换术是全球最常见的心脏外科手术之一。传统的主动脉瓣置换手术通过正中胸骨切开术进行；胸骨从胸骨切迹到剑突完全切开。微创主动脉瓣置换术采用一种名为胸骨柄有限小切口胸骨切开术的新技术，仅将胸骨柄从胸骨切迹到胸骨柄-胸骨交界处下方1厘米处切开。超过三分之一接受传统胸骨切开术的患者出现具有临床意义的出血，需要术后输注红细胞。病例系列数据表明，两种技术在红细胞输注需求方面可能存在具有临床意义的差异。考虑到对国家医疗服务资源和患者预后的影响，需要进行一项确定性试验。
方法/设计：这是一项单中心、单盲、随机对照试验，比较采用胸骨柄有限小切口胸骨切开术（干预）和传统正中胸骨切开术（常规治疗）进行主动脉瓣置换手术的效果。270名患者将按1:1的比例随机分配到干预组和对照组，根据基线逻辑欧洲心脏手术风险评估系统（EuroSCORE）和血红蛋白值进行分层。患者将在首次手术出院后随访12周。主要结局是术后7天内接受红细胞输注的患者比例。次要结局包括红细胞和血液制品输注、失血量、再次手术率、胸骨伤口疼痛、生活质量、炎症反应标志物、出院情况、医疗保健利用、成本和成本效益以及不良事件。
这是第一项比较手术后脑脊液引流与腰椎穿刺对红细胞输注率影响的试验，研究通过胸骨柄有限小切口胸骨切开术与传统胸骨切开术进行主动脉瓣置换。外科试验面临重大挑战；本试验的优势包括严谨的研究设计、由经验丰富的心胸外科顾问医生进行标准化手术、商定的麻醉方案、患者盲法以及由顾问主导的患者招募。MAVRIC试验将证明复杂的外科试验可以达到示范标准，并为社区提供为需要主动脉瓣置换手术的患者提供未来护理所需的知识。
国际标准随机对照试验编号（ISRCTN）ISRCTN29567910。于2014年2月3日注册。
