Clinical trial NCT02105532: Transfusion in Gastrointestinal Bleeding
Official title: A Multi-centre, Feasibility, Cluster Randomised Controlled Trial Comparing Restrictive Versus Liberal Blood Transfusion Strategies in Adult Patients Admitted With Acute Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastrointestinal Hemorrhage
Keywords: Transfusion in gastrointestinal bleeding
Lead sponsor: NHS Blood and Transplant
Sponsor class: OTHER_GOV
Collaborators: name: NHS Blood and Transplant
First posted: 2014-04-07
Enrollment: 936
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the feasibility and safety of 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.

Detailed description: Trial overview: TRIGGER is a pragmatic trial aiming to recruit adult patients admitted with all cause AUGIB (non-variceal and variceal). The study will take place in six United Kingdon hospitals and they will be randomly allocated to a transfusion policy at the cluster level; three sites will be allocated to a restrictive transfusion policy and three to a liberal transfusion policy. Given the challenges that will be involved in early recruitment and cross-speciality care, a feasibility study is essential to determine whether a sufficient proportion of eligible patients can be recruited into the trial and that clinicians can adhere to the allocated transfusion policy. Recruitment will operate for 6 months in total. The investigators will compare recruitment rate, protocol adherence, clinical characteristics of patients recruited, exposure to RBC transfusions and the difference in Hb concentrations between the restrictive and liberal transfusion policies. The investigators will collect important clinical outcomes which the investigators anticipate being central to the phase III trial, including 28-day mortality, further bleeding rates and serious adverse events between the restrictive and liberal transfusion policies. The investigators will also collect data to enable us to plan a health economic evaluation and quality of life assessment for the phase III trial.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena.

Exclusion Criteria:

* Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding.
* Existing hospital in-patients who develop AUGIB.

Primary outcomes:
measure: Adherence to the study protocol
timeFrame: up to 28 days
Secondary outcomes:
measure: Further Bleeding
timeFrame: up to 28 days
Other outcomes:
measure: Red Blood Cell exposure in patients
timeFrame: up to 28 days
measure: Selection bias
timeFrame: 6 months
measure: Difference in Hb concentration Between Restrictive and Liberal Groups
timeFrame: up to 28 days
measure: Death
timeFrame: up to 28 days
measure: Need for therapeutic intervention at the index endoscopy
timeFrame: up to 28 days
measure: Need for surgery or radiological intervention to control bleeding
timeFrame: up to 28 days
measure: Proportion of patients experiencing the composite endpoint of thromboembolic and ischaemic events up to Day 28
timeFrame: up to 28 days
measure: Acute Transfusion reactions up to death/ discharge
timeFrame: up to 28 days
measure: Infections
timeFrame: up to 28 days
measure: Length of hospital stay
timeFrame: up to 28 days
measure: Health related quality of life at Day 28
timeFrame: 28 days
Locations:
city: Oxford
country: United Kingdom
facility: NHSBT Clinical Studies Unit
Study officials:
affiliation: NHS Blood and Transplant
name: Professor Michael F Murphy
role: STUDY_CHAIR
affiliation: NHSBT and Translational Gastroenterology Unit, Oxford, UK.
name: Vipul Jairath
role: STUDY_DIRECTOR
References:
citation: Kahan BC, Jairath V. Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study. Trials. 2018 May 2;19(1):265. doi: 10.1186/s13063-018-2654-z.
citation: Jairath V, Kahan BC, Gray A, Dore 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. Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial. Lancet. 2015 Jul 11;386(9989):137-44. doi: 10.1016/S0140-6736(14)61999-1. Epub 2015 May 5.
citation: Campbell HE, Stokes EA, Bargo D, Logan RF, Mora A, Hodge R, Gray A, James MW, Stanley AJ, Everett SM, Bailey AA, Dallal H, Greenaway J, Dyer C, Llewelyn C, Walsh TS, Travis SP, Murphy MF, Jairath V; TRIGGER investigators. Costs and quality of life associated with acute upper gastrointestinal bleeding in the UK: cohort analysis of patients in a cluster randomised trial. BMJ Open. 2015 Apr 29;5(4):e007230. doi: 10.1136/bmjopen-2014-007230.