Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
Bristol Heart Institute, University of Bristol, Bristol, UK.
BMJ Open. 2019 Apr 2;9(4):e026221. doi: 10.1136/bmjopen-2018-026221.
Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve. Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB).
We are conducting a multicentre, single-blind randomised controlled trial in patients with congenital heart disease and aged between 12 and 80 years. We will randomise participants in a 1:1 ratio to receive either 'off pump' injectable pulmonary valve replacement or 'on pump' conventional pulmonary valve replacement. The primary outcome will be the difference between the groups with respect to post-surgery blood loss (as measured by chest drain volume) in the first 24 hours. Secondary outcomes will include in-hospital outcomes (intensive care unit stay, inotropic/vasodilator support, chest drain volume in the first 12 hours post-surgery, time of readiness for extubation, blood products used in the first 24 hours post-surgery, time of fitness for discharge, valve and heart function 6 months post-surgery (assessed using cardiovascular magnetic resonance and ECHOCARDIOGRAPHY) and health-related quality of life 6 weeks and 6 months post-surgery.
This trial has been approved by the South West Exeter Research Ethics Committee. Findings will be shared with participating hospitals and disseminated to the academic community through peer reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and newsletters to participants.
ISRCTN23538073.
患有先天性心脏病的患者在其一生中通常需要多次手术来更换肺动脉瓣。与使用体外循环（CPB）的传统瓣膜置换（即“泵上”瓣膜置换）相比，使用“可注射”自膨式瓣膜进行瓣膜置换（即“无泵”瓣膜置换，不使用 CPB）可能导致更快的恢复和更低的主要并发症风险。
我们正在对年龄在 12 至 80 岁之间的先天性心脏病患者进行一项多中心、单盲随机对照试验。我们将以 1:1 的比例随机分配参与者接受“无泵”可注射肺动脉瓣置换或“泵上”传统肺动脉瓣置换。主要结局将是两组之间在术后 24 小时内（通过胸腔引流体积测量）的术后出血量差异。次要结局将包括住院期间的结局（重症监护病房停留时间、正性肌力/血管扩张支持、术后 12 小时内的胸腔引流体积、拔管准备时间、术后 24 小时内使用的血液制品、出院时的身体状况、术后 6 个月的瓣膜和心脏功能（使用心血管磁共振和超声心动图评估）以及术后 6 周和 6 个月的健康相关生活质量。
这项试验已获得西南埃克塞特研究伦理委员会的批准。研究结果将与参与的医院共享，并通过同行评审的出版物和在国家和国际会议上的报告传播给学术界。将通过患者组织和给参与者的通讯向患者通报结果。
ISRCTN23538073。
