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Transfusion in Gastrointestinal Bleeding

NCT02105532 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2014-04-07

No results posted yet for this study

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

Interventions

OTHER

Restrictive transfusion policy

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

Liberal Transfusion Policy

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.

Sponsors & Collaborators

  • NHS Blood and Transplant

    collaborator OTHER_GOV

  • Dr Vipul Jairath

    lead OTHER_GOV

Principal Investigators

  • Professor Michael F Murphy · NHS Blood and Transplant

  • Vipul Jairath · NHSBT and Translational Gastroenterology Unit, Oxford, UK.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105532 on ClinicalTrials.gov