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

Dhiraj Tripathi; David Patch; Homoyon Mehrzad; Dominic Yu; Richard J Aspinall; Matthew J Armstrong; Adrian J Stanley; Hamish  Ireland; Simon Travis; Peter Hayes; Mandy  Lomax; Nicholas  Roslund; Emily  Lam; Gemma Slinn; Sue Jowett; Catherine Moakes; Alisha Maher; Elizabeth Brettell; Sukhi Sehmi; REACT-AVB trial collaborative group

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^*, David Patch, Homoyon Mehrzad, Dominic Yu, Richard J Aspinall, Matthew J Armstrong, Adrian J Stanley, Hamish Ireland, Simon Travis, Peter Hayes, Mandy Lomax, Nicholas Roslund, Emily Lam, Gemma Slinn, Sue Jowett, Catherine Moakes, Alisha Maher, Elizabeth Brettell, Sukhi Sehmi, REACT-AVB trial collaborative group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	e001314
Number of pages	10
Journal	BMJ Open Gastroenterology
Volume	11
Issue number	1
DOIs	https://doi.org/10.1136/bmjgast-2023-001314
Publication status	Published - 22 Mar 2024

Bibliographical note

Funding:
This work was supported by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (funding reference number: NIHR130883). Date of design was 27 November 2019 and of funding was 1 December 2021. The funder had no role with respect to the trial design; collection, management, analysis and interpretation of the data; writing the report; and the decision to submit the report for publication. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.

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10.1136/bmjgast-2023-001314Licence: Creative Commons: Attribution (CC BY)

TripathiD2024StudyFinal published version, 705 KBLicence: Creative Commons: Attribution (CC BY)

Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB)
Moakes, C., Brocklehurst, P., Slinn, G. & Jowett, S.
NIHR
1/12/21 → 30/11/27
Project: Other Government Departments

Cite this

Tripathi, D., Patch, D., Mehrzad, H., Yu, D., Aspinall, R. J., Armstrong, M. J., Stanley, A. J., Ireland, H., Travis, S., Hayes, P., Lomax, M., Roslund, N., Lam, E., Slinn, G., Jowett, S., Moakes, C., Maher, A., Brettell, E., Sehmi, S., & REACT-AVB trial collaborative group (2024). Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in Acute Variceal Bleeding (REACT-AVB trial). BMJ Open Gastroenterology, 11(1), Article e001314. https://doi.org/10.1136/bmjgast-2023-001314

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

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.",

author = "Dhiraj Tripathi and David Patch and Homoyon Mehrzad and Dominic Yu and Aspinall, {Richard J} and Armstrong, {Matthew J} and Stanley, {Adrian J} and Hamish Ireland and Simon Travis and Peter Hayes and Mandy Lomax and Nicholas Roslund and Emily Lam and Gemma Slinn and Sue Jowett and Catherine Moakes and Alisha Maher and Elizabeth Brettell and Sukhi Sehmi and {REACT-AVB trial collaborative group}",

note = "Funding: This work was supported by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (funding reference number: NIHR130883). Date of design was 27 November 2019 and of funding was 1 December 2021. The funder had no role with respect to the trial design; collection, management, analysis and interpretation of the data; writing the report; and the decision to submit the report for publication. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.",

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month = mar,

day = "22",

doi = "10.1136/bmjgast-2023-001314",

language = "English",

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Tripathi, D, Patch, D, Mehrzad, H, Yu, D, Aspinall, RJ, Armstrong, MJ, Stanley, AJ, Ireland, H, Travis, S, Hayes, P, Lomax, M, Roslund, N, Lam, E, Slinn, G, Jowett, S , Moakes, C , Maher, A , Brettell, E , Sehmi, S & REACT-AVB trial collaborative group 2024, 'Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in Acute Variceal Bleeding (REACT-AVB trial)', BMJ Open Gastroenterology, vol. 11, no. 1, e001314. https://doi.org/10.1136/bmjgast-2023-001314

TY - JOUR

T1 - Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in Acute Variceal Bleeding (REACT-AVB trial)

AU - Tripathi, Dhiraj

AU - Patch, David

AU - Mehrzad, Homoyon

AU - Yu, Dominic

AU - Aspinall, Richard J

AU - Armstrong, Matthew J

AU - Stanley, Adrian J

AU - Ireland, Hamish

AU - Travis, Simon

AU - Hayes, Peter

AU - Lomax, Mandy

AU - Roslund, Nicholas

AU - Lam, Emily

AU - Slinn, Gemma

AU - Jowett, Sue

AU - Moakes, Catherine

AU - Maher, Alisha

AU - Brettell, Elizabeth

AU - Sehmi, Sukhi

AU - REACT-AVB trial collaborative group

N1 - Funding: This work was supported by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (funding reference number: NIHR130883). Date of design was 27 November 2019 and of funding was 1 December 2021. The funder had no role with respect to the trial design; collection, management, analysis and interpretation of the data; writing the report; and the decision to submit the report for publication. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.

PY - 2024/3/22

Y1 - 2024/3/22

N2 - 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.

AB - 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.

U2 - 10.1136/bmjgast-2023-001314

DO - 10.1136/bmjgast-2023-001314

M3 - Article

SN - 2054-4774

VL - 11

JO - BMJ Open Gastroenterology

JF - BMJ Open Gastroenterology

IS - 1

M1 - e001314

ER -

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

Abstract

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

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