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Completed

NCT Number: NCT02105532

Transfusion in Gastrointestinal Bleeding

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NHSBT Clinical Studies Unit

Oxford, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Adherence to the study protocol

    Time frame: up to 28 days

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

Secondary outcomes

  1. Further Bleeding

    Time frame: up to 28 days

    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.

Other outcomes

  1. Red Blood Cell exposure in patients

    Time frame: up to 28 days

    The difference in number of red blood cell units administered will be compared between the intervention groups up to discharge/death/Day 28 (whichever comes first).

  2. Selection bias

    Time frame: 6 months

    Clinical characteristics of patients in the two transfusion policies

  3. Difference in Hb concentration Between Restrictive and Liberal Groups

    Time frame: up to 28 days

    The mean Hb values for patients will be compared between the treatment arms up to discharge/death/Day 28 (whichever comes first).

  4. Death

    Time frame: up to 28 days

    All-cause mortality up to Day 28.

  5. Need for therapeutic intervention at the index endoscopy

    Time frame: up to 28 days

    This includes any therapeutic modality performed for AUGIB at the index endoscopy.

  6. Need for surgery or radiological intervention to control bleeding

    Time frame: up to 28 days

  7. Proportion of patients experiencing the composite endpoint of thromboembolic and ischaemic events up to Day 28

    Time frame: up to 28 days

    Includes myocardial infarction, stroke, pulmonary embolus, Deep Vein Thrombosis, acute kidney injury. Each component will also be assessed individually. See section 8.1.3 for a definition of ischaemic and thromboembolic events.

  8. Acute Transfusion reactions up to death/ discharge

    Time frame: up to 28 days

    Defined as a reaction occurring at any time up to 24 hours following a transfusion of a blood component.

  9. Infections

    Time frame: up to 28 days

    Any infection necessitating a prescription for the use of antibiotic treatment for a minimum of 5 days, provided the prescription is received before or on Day 28.

  10. Length of hospital stay

    Time frame: up to 28 days

  11. Health related quality of life at Day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Dr Vipul Jairath

Other Gov

Collaborators

  • NHS Blood and Transplant

Registry information

Official study 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

Acronym: TRIGGER

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 7, 2014
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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