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Abstract：
BACKGROUND: In liver cirrhosis, acute variceal bleeding (AVB) is associated with a 1-year mortality rate of up to 40%. Data on early or pre-emptive transjugular intrahepatic portosystemic stent-shunt (TIPSS) in AVB is inconclusive and may not reflect current management strategies. Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in AVB (REACT-AVB) aims to investigate the clinical and cost-effectiveness of early TIPSS in patients with cirrhosis and AVB after initial bleeding control.
METHODS: REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7-13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK.
BACKGROUND: Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication.
BACKGROUND: ISRCTN85274829; protocol version 3.0, 1 July 2023.
METHODS: REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7-13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK.
BACKGROUND: Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication.
BACKGROUND: ISRCTN85274829; protocol version 3.0, 1 July 2023.
摘要：
背景：在肝硬化中，急性静脉曲张破裂出血(AVB)的1年死亡率高达40%.AVB早期或抢先性经颈静脉肝内门体支架分流术（TIPSS）的数据尚无定论，可能无法反映当前的管理策略。AVB（REACT-AVB）的EArly经颈静脉内肝内动脉静脉分流术的随机对照试验旨在研究初始出血控制后肝硬化和AVB患者早期TIPSS的临床和成本效益。
方法：REACT-AVB是一个多中心，随机对照，开放标签，优越性,双臂，内部飞行员的平行组试验。随机1：1分配的两种干预措施是诊断性内窥镜检查后4天内的早期TIPSS或内窥镜治疗联合非选择性β受体阻滞剂的二级预防。年龄≥18岁的肝硬化和Child-Pugh评分7-13表现为AVB内镜止血的患者有资格入选。主要结果是随机化后1年的无移植存活率。次要终点包括6周无移植生存期，再出血,严重不良事件,肝硬化的其他并发症，Child-Pugh和终末期肝病模型（MELD）评分在6个月和12个月，与健康相关的生活质量，利用医疗保健资源，交叉治疗的成本效益和使用。在4年的招募期内，样本量为294名患者，在英国的30家医院。
背景：国家卫生服务研究伦理委员会已批准REACT-AVB（参考号：23/WM/0085）。结果将提交给同行评审的期刊发表。在发布之前，还将通过电子邮件发送或发布给参与者。
背景：ISRCTN85274829；协议版本3.0，2023年7月1日。
方法：REACT-AVB是一个多中心，随机对照，开放标签，优越性,双臂，内部飞行员的平行组试验。随机1：1分配的两种干预措施是诊断性内窥镜检查后4天内的早期TIPSS或内窥镜治疗联合非选择性β受体阻滞剂的二级预防。年龄≥18岁的肝硬化和Child-Pugh评分7-13表现为AVB内镜止血的患者有资格入选。主要结果是随机化后1年的无移植存活率。次要终点包括6周无移植生存期，再出血,严重不良事件,肝硬化的其他并发症，Child-Pugh和终末期肝病模型（MELD）评分在6个月和12个月，与健康相关的生活质量，利用医疗保健资源，交叉治疗的成本效益和使用。在4年的招募期内，样本量为294名患者，在英国的30家医院。
背景：国家卫生服务研究伦理委员会已批准REACT-AVB（参考号：23/WM/0085）。结果将提交给同行评审的期刊发表。在发布之前，还将通过电子邮件发送或发布给参与者。
背景：ISRCTN85274829；协议版本3.0，2023年7月1日。
