REACT-AVB

NIHR LOGO

 

REACT-AVB -Randomised controlled trial of early transjugular intrahepatic portosystemic stent-shunt in acute variceal bleeding

 

REACT-AVB LOGO

REACT-AVB IS OPEN TO RECRUITMENT

Join us at the REACT-AVB webinar on the 25th November 2024 between 1.00pm and 2.00pm

zoom link: https://bham-ac-uk.zoom.us/meeting/register/tZYtc-itrzovEtCv-eY0gmoMO3ApcMNbPFT1

Design

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.

Aim of Study

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).

Setting

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

Target population

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.

Intervention

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.

Further Information

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

Latest News!

We are excited to announce that three new sites have received approval to begin recruiting at their respective hospitals. In Scotland, Glasgow Royal Infirmary and Queen Elizabeth University Hospital officially commenced recruitment on the 4th October 2024. Meanwhile, Derriford Hospital in Plymouth opened its recruitment doors on the 24th September 2024. 

We extend our heartfelt thanks to our dedicated colleagues at all three hospitals for their invaluable support during the site setup process. We eagerly anticipate the recruitment of their first patients in the near future. 

Stay tuned for further updates!