Transfusion in Gastrointestinal Bleeding (TRIGGER)

Conditions

Non-malignant haematology Surgery

Jairath V, Kahan BC, Gray A, Doré CJ, Mora A, James MW, Stanley AJ, Everett SM, Bailey AA, Dallal H, Greenaway J, Le Jeune I, Darwent M, Church N, Reckless I, Hodge R, Dyer C, Meredith S, Llewelyn C, Palmer KR, Logan RF, Travis SP, Walsh TS, Murphy MF.

2015-05-05154 citations

10.1016/s0140-6736(14)61999-1

Costs and quality of life associated with acute upper gastrointestinal bleeding in the UK: cohort analysis of patients in a cluster randomised trial

Helen Campbell, Elizabeth A Stokes, Danielle Bargo, R F Logan, Ana Sabrina Mora et al. (31 authors)

BMJ Open2015-04-2983 citations

10.1136/bmjopen-2014-007230

Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials

Brennan C Kahan, Suzie Cro, Caroline J Doré, Daniel J. Bratton, Sunita Rehal et al. (8 authors)

Trials2014-11-21112 citations

10.1186/1745-6215-15-456

Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial.

Kahan BC, Jairath V, Murphy MF, Doré CJ.

2013-07-1013 citations

10.1186/1745-6215-14-206

Interventions

Transfusion Policies: The trial will compare two different policies for RBC transfusion, 'restrictive' and 'liberal'. Restrictive transfusion policy: Patients in hospi

Follow Up Length: 1 month(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged = 18 years presenting with AUGIB, defined by haematemesis or melaena. 2. >20 admissions with AUGIB per month 3. >400 hospital beds 4. Availability of 24 hours endoscopy and on-site access to intensive care and surgical support 5. Institutional agreement to transfuse all eligible new admissions with AUGIB in accordance with the randomised transfusion policy 6. Male & female participants 7. Lower Age Limit 18 years

Exclusion criteria

Exclusion criteria: 1. Patients for whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Haemoglobin (Hb) result due to severity of bleeding (these patients should be managed according to the hospital's massive transfusion protocol or clinician discretion) 2. Existing hospital inpatients who develop an AUGIB

Design outcomes

Primary

Measure	Time frame
1. Protocol adherence 2. Selection bias 3. Recruitment rate 4. Red cell exposure 5. Information to inform the sample size of the phase III trial Clinical Outcomes: Further bleeding up to Day 28: Further bleeding is a composite outcome that includes persistent bleeding	—

Secondary

Measure	Time frame
1. Further bleeding 2. 28-day mortality 3. Infections 4. Ischaemic/thromboembolic events We will also collect data to guide a Health Economic evaluation for the phase III trial.	—

Countries

United Kingdom

Outcome results

None listed