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Transfusion in Gastrointestinal Bleeding (TRIGGER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105532
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
NHS Blood and Transplant
Information provided by (Responsible Party):
Dr Vipul Jairath, NHS Blood and Transplant

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Other: Restrictive transfusion policy Other: Liberal Transfusion Policy Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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: 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.
Active Comparator: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105532


Locations
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United Kingdom
NHSBT Clinical Studies Unit
Oxford, United Kingdom
Sponsors and Collaborators
Dr Vipul Jairath
NHS Blood and Transplant
Investigators
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Study Chair: Professor Michael F Murphy NHS Blood and Transplant
Study Director: Vipul Jairath NHSBT and Translational Gastroenterology Unit, Oxford, UK.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Vipul Jairath, Research Fellow in Gastroneterology, NHS Blood and Transplant
ClinicalTrials.gov Identifier: NCT02105532    
Other Study ID Numbers: 10-09-CSU
ID 12078 ( Other Identifier: NIHR )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by Dr Vipul Jairath, NHS Blood and Transplant:
Transfusion in gastrointestinal bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases