{Reference Type}: Clinical Trial Protocol
{Title}: Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial).
{Author}: Tripathi D;Patch D;Mehrzad H;Yu D;Aspinall RJ;Armstrong MJ;Stanley A;Ireland H;Travis S;Hayes P;Lomax M;Roslund N;Lam E;Slinn G;Jowett S;Moakes C;Maher A;Brettell E;Sehmi S; ;
{Journal}: BMJ Open Gastroenterol
{Volume}: 11
{Issue}: 1
{Year}: 2024 Mar 22
暂无{DOI}: 10.1136/bmjgast-2023-001314
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>BACKGROUND: </B>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.<BR><B>BACKGROUND: </B>ISRCTN85274829; protocol version 3.0, 1 July 2023.