TRIGGER
The TRIGGER study is now complete.
Transfusion in gastrointestinal bleeding
Chief investigators: Prof Mike Murphy and Dr Vipul Jairath
Primary sponsor: NHSBT
Funder: NHSBT
Summary
A multicentre, feasibility, cluster randomised trial comparing restrictive versus liberal blood transfusion strategies in adult patients with acute upper gastrointestinal bleeding.
Study hypothesis
To evaluate the feasibility and safety of implementing a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with acute upper gastrointestinal bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.
Study design
Cluster randomised trial. Hospitals will be allocated at random to either the restrictive or liberal transfusion policy.
Findings
The protocol was feasible, recruited ahead of target and generated clinically important differences in the level of anaemia and RBC exposure during hospitalisation. There was a consistent trend towards fewer complications in the restrictive arm, apart from the increased mortality observed in patients with ischaemic heart disease, some of which could be partially explained by imbalances in baseline risk.
A large trial is required to clarify the risk-benefit balance before advocating restrictive RBC transfusion for all patients with AUGIB.
Publications
Jairath V, Kahan BC, Logan RFA, Travis SPL, Palmer KR, Murphy MF. Red blood cell transfusion practice in patients presenting with acute upper gastrointestinal bleeding: a survey of 815 UK clinicians. Transfusion 2011; 51:1940-1948 [E Pub 24 Mar 2011 doi: 10.1111/j.1537-2995.2011.03119.x]
Jairath V, Kahan BC, Logan RFA, Hearnshaw SA, Travis SPL, Palmer KR, Murphy MF. Mortality From Acute Upper Gastrointestinal Bleeding in the United Kingdom: Does It Display a “Weekend Effect”? Am J Gastroenterol. 2011; 106: 1621-1628. [E Pub 24 May 2011 doi:10.1038/ajg.2011.172]
Jairath V, Kahan BC, Logan RF, Hearnshaw SA, Doré CJ, Travis SP, Murphy MF, Palmer KR. Outcomes following acute nonvariceal upper gastrointestinal bleeding in relation to time to endoscopy: results from a nationwide study. Endoscopy. 2012; 44(8):723-30. [Epub 02 Jul 2012 doi: 10.1055/s-0032-1309736]
Jairath V, Kahan BC, Logan RF, Hearnshaw SA, Dore CJ, Travis SP, Murphy MF, Palmer KR. National audit of the use of surgery and radiological embolization after failed endoscopic haemostasis for non-variceal upper gastrointestinal bleeding.Br J Surg; 2012 99(12):1672-80. [Epub 28 Sep 2012 doi: 10.1002/bjs.8932]
Jairath V, Kahan BC, Stanworth SJ, Logan RF, Hearnshaw SA, Travis SP, Palmer KR, Murphy MF. Prevalence, management, and outcomes of patients with coagulopathy after cute nonvariceal upper gastrointestinal bleeding in the United Kingdom. Transfusion 2013; 53 (5): 1069-76 [E Pub 15 Aug 2012 doi:10.1111/j.1537-2995.2012.03849.x]
Jairath V, Kahan BC, Gray A, Dore CJ, Mora A, Dyer C, Stokes EA, Llewelyn C, Bailey AA, Dallal H, Everett, SM, James MW, Stanley AJ, Church N, Darwent M, Greenaway J, Le Jeune I, Reckless I, Campbell HE, Meredith S, Palmer KR, Logan RFA, Travis SPL, Walsh TS, Murphy MF. Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: Rationale and protocol for a cluster randomised feasibility trial. Transfus Med Rev 2013; 27 (3): 146-53 [Epub 22 May 2013 doi: 10.1016/j.tmrv.2013.04.001]
Kahan BC, Jairath V, Murphy MF, and Dore CJ. Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial. Trials 2013; 14, 206 [Epub 10 Jul 2013; doi10.1186/1745-6216-14-206]
Jairath V, Kahan BC, Gray A, et al, Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open label, cluster feasibility trial. The Lancet 2015 Vol 386; No 9989, p137-144, 11 July 2015
Campbell H, Stokes EA, Bargo D, Mora A, et al. Costs and Quality of Life associated with acute upper gatrointestinal bleeding in the UK: cohort analysis of patients in a cluster randomised trial. BMJ Open 2015 5: e007230. doi:10.1136/bmjopen-2014-007230