REACT-AVB

The REACT-AVB study is a pragmatic, multicentre randomised controlled trial.  It has an open label, superiority two arm parallel group design, with a 12 month internal pilot phase.  Recruited participants will be followed up at three time points; 6 weeks post randomisation, 6 months and 12 months.

To investigate the clinical and cost-effectiveness of early transjugular intrahepatic portosystemic stent-shunt (TIPSS) versus endoscopic plus pharmacological therapy in patients with cirrhosis and acute variceal bleeding after initial control of bleeding by variceal band ligation (VBL).

Acute NHS Trusts and Health Boards in the UK that admit and manage patients with acute variceal bleeding.

Patients with liver cirrhosis presenting with acute variceal bleeding which has been controlled by current therapy as recommended in the British Society of Gastroenterology (BSG) guidelines. A sample size of 294 patients (1:1 randomisation) is required to show improved transplant free survival at one year from 60% to 80% with early TIPSS with 90% power (alpha=0.05), and allowing for 20% attrition.

Patients will be randomised at the level of the individual in a 1:1 ratio to receive either: 

Early transjugular intrahepatic portosystemic stent-shunt (TIPSS) within 4 days of diagnostic endoscopy.

Or;

Endoscopic therapy and non-selective beta-blocker.

Chief Investigator:   Prof. Dhiraj Tripathi

Co-Chief Investigator:   Dr David Patch

Funder: National Institute For Health Research (HTA programme [Ref: NIHR130883])

Sponsor: University of Birmingham

Coordinating Centre: Birmingham Clinical Trials Unit