. 2024 Mar 22;11(1):e001314.

doi: 10.1136/bmjgast-2023-001314.

Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial)

Dhiraj Tripathi^{1

2}, David Patch³, Homoyon Mehrzad⁴, Dominic Yu⁵, Richard J Aspinall⁶, Matthew J Armstrong⁷, Adrian Stanley⁸, Hamish Ireland⁹, Simon Travis¹⁰, Peter Hayes¹¹, Mandy Lomax¹², Nicholas Roslund¹³, Emily Lam¹⁴, Gemma Slinn¹⁵, Sue Jowett¹⁶, Catherine Moakes¹⁵, Alisha Maher¹⁵, Elizabeth Brettell¹⁵, Sukhwant Sehmi¹⁵; REACT-AVB trial collaborative group

Collaborators, Affiliations

Collaborators

Affiliations

¹ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK d.tripathi@bham.ac.uk.
² Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
³ Hepatology and Liver Transplantation, Royal Free Hampstead NHS Trust, London, UK.
⁴ Interventional Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
⁵ Department of Radiology, Royal Free London NHS Foundation Trust, London, UK.
⁶ Gastroenterology and Hepatology, Portsmouth Hospitals NHS Trust, Portsmouth, UK.
⁷ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
⁸ GI Unit, Glasgow Royal Infirmary, Glasgow, Glasgow, UK.
⁹ Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.
¹⁰ Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹¹ Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.
¹² Walton-on-Thames, Walton-on-Thames, UK.
¹³ London, London, UK.
¹⁴ GI and Liver PPI Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
¹⁵ Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.
¹⁶ Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK.

PMID: 38519049
PMCID: PMC10966777
DOI: 10.1136/bmjgast-2023-001314

Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial)

Dhiraj Tripathi et al. BMJ Open Gastroenterol. 2024.

. 2024 Mar 22;11(1):e001314.

doi: 10.1136/bmjgast-2023-001314.

Authors

Collaborators

Affiliations

¹ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK d.tripathi@bham.ac.uk.
² Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
³ Hepatology and Liver Transplantation, Royal Free Hampstead NHS Trust, London, UK.
⁴ Interventional Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
⁵ Department of Radiology, Royal Free London NHS Foundation Trust, London, UK.
⁶ Gastroenterology and Hepatology, Portsmouth Hospitals NHS Trust, Portsmouth, UK.
⁷ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
⁸ GI Unit, Glasgow Royal Infirmary, Glasgow, Glasgow, UK.
⁹ Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.
¹⁰ Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹¹ Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.
¹² Walton-on-Thames, Walton-on-Thames, UK.
¹³ London, London, UK.
¹⁴ GI and Liver PPI Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
¹⁵ Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.
¹⁶ Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK.

PMID: 38519049
PMCID: PMC10966777
DOI: 10.1136/bmjgast-2023-001314

Abstract

Introduction: 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 and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: ISRCTN85274829; protocol version 3.0, 1 July 2023.

Keywords: CIRRHOSIS; GASTROINTESTINAL BLEEDING; OESOPHAGEAL VARICES; PORTAL HYPERTENSION; STENTS.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 2**
Details of health technologies. NSBB, non-selective beta blocker; TIPSS, transjugular intrahepatic portosystemic stent–shunt.

See this image and copyright information in PMC

Cited by

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Pre-emptive TIPSS in Acute Variceal Bleeding: Current Status, Controversies, and Future Directions.
Wong YJ, Ho WLD, Abraldes JG. Wong YJ, et al. J Clin Transl Hepatol. 2022 Dec 28;10(6):1223-1228. doi: 10.14218/JCTH.2022.00240. Epub 2022 Jul 29. J Clin Transl Hepatol. 2022. PMID: 36381087 Free PMC article. Review.

References

1. NICE . Cirrhosis in over 16S: assessment and management. London: NICE, 2016. - PubMed
1. Jairath V, Rehal S, Logan R, et al. . Acute Variceal haemorrhage in the United kingdom: patient characteristics, management and outcomes in a nationwide audit. Dig Liver Dis 2014;46:419–26. 10.1016/j.dld.2013.12.010 - DOI - PubMed
1. Tripathi D, Stanley AJ, Hayes PC, et al. . Guidelines on the management of Variceal haemorrhage in Cirrhotic patients. Gut 2015;64:1680–704. 10.1136/gutjnl-2015-309262 - DOI - PMC - PubMed
1. de Franchis R, Bosch J, Garcia-Tsao G, et al. . Renewing consensus in portal hypertension. J Hepatol 2022;76:959–74. 10.1016/j.jhep.2021.12.022 - DOI - PMC - PubMed
1. Maimone S, Saffioti F, Filomia R, et al. . Predictors of re-bleeding and mortality among patients with refractory Variceal bleeding undergoing salvage Transjugular Intrahepatic Portosystemic shunt (TIPS). Dig Dis Sci 2019;64:1335–45. 10.1007/s10620-018-5412-x - DOI - PubMed

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Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial)

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Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial)

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