Transfusion in Gastrointestinal Bleeding

NCT02105532 | Completed Phase 2 DMC

• 2 other identifiers: 10-09-CSUID 12078
• Study Type: interventional
• Target: 936
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hemorrhage

Keywords

Transfusion in gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• Adherence to the study protocol

  Protocol adherence will be measured over time, to determine if adherence rates improve. Adherence rates will also be compared between transfusion arms.

  up to 28 days

Secondary Outcomes (1)

• Further Bleeding

  up to 28 days

Other Outcomes (11)

• Red Blood Cell exposure in patients

  up to 28 days

• Selection bias

  6 months

• Difference in Hb concentration Between Restrictive and Liberal Groups

  up to 28 days

Study Arms (2)

Restrictive Transfusion Policy

ACTIVE COMPARATOR

Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 8 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 8.1-10 g/dL for the duration of hospital stay.

Other: Restrictive transfusion policy

Liberal Transfusion Policy

ACTIVE COMPARATOR

Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 10 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 10.1-12 g/dL for the duration of hospital stay.

Other: Liberal Transfusion Policy

Interventions

Restrictive transfusion policy OTHER

Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 8 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 8.1-10 g/dL for the duration of hospital stay.

Restrictive Transfusion Policy

Liberal Transfusion Policy OTHER

Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 10 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 10.1-12 g/dL for the duration of hospital stay.

Liberal Transfusion Policy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Vipul Jairath: lead
• NHS Blood and Transplant: collaborator

Study Sites (1)

NHSBT Clinical Studies Unit

Oxford, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29720248 DERIVED

• 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.

  PMID: 25956718 DERIVED

• 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.

  PMID: 25926146 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Michael F Murphy

  NHS Blood and Transplant

  STUDY CHAIR

• Vipul Jairath

  NHSBT and Translational Gastroenterology Unit, Oxford, UK.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow in Gastroneterology

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: April 7, 2014
• Study Start: September 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

GB (1)