Transfusion in Gastrointestinal Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-centre, Feasibility, Cluster Randomised Controlled Trial Comparing Restrictive Versus Liberal Blood Transfusion Strategies in Adult Patients Admitted With Acute Upper Gastrointestinal Bleeding

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Other: Restrictive transfusion policy
* Other: Liberal Transfusion Policy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive Transfusion Policy<br>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<br>* 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.<br>|
| Active Comparator: Liberal Transfusion Policy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further Bleeding | Further bleeding up to Day 28: Further bleeding is a composite outcome that includes persistent bleeding (defined as any bleeding present at the end of the index endoscopy, regardless of whether endoscopic therapy was attempted or not), and recurrent bleeding. Recurrent bleeding is only assessed in patients without persistent bleeding, and must be confirmed by the presence of high-risk stigmata of bleeding either endoscopically, radiologically, or surgically. Recurrent bleeding should initially be suspected in the event of any combination of the following: fresh haematemesis, continuous melaena, or aspiration of fresh blood from a naso-gastric tube, with a pulse rate of >100 bpm, a fall in systolic blood pressure of >30mm Hg or a drop in Hb of >2g/dL in the preceding 24 hours. Persistent bleeding and recurrent bleeding will also be assessed separately. | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion in gastrointestinal bleeding