Transfusion in Gastrointestinal Bleeding

Gastrointestinal Hemorrhage Clinical Trial

— TRIGGER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105532
• Other study ID #: 10-09-CSU
• Secondary ID: ID 12078
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2012
• Last updated: April 2, 2014
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: NHS Blood and Transplant
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 936
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	NHSBT Clinical Studies Unit	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Dr Vipul Jairath	NHS Blood and Transplant

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Red Blood Cell exposure in patients	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).	up to 28 days	Yes
Other	Selection bias	Clinical characteristics of patients in the two transfusion policies	6 months	No
Other	Difference in Hb concentration Between Restrictive and Liberal Groups	The mean Hb values for patients will be compared between the treatment arms up to discharge/death/Day 28 (whichever comes first).	up to 28 days	No
Other	Death	All-cause mortality up to Day 28.	up to 28 days	Yes
Other	Need for therapeutic intervention at the index endoscopy	This includes any therapeutic modality performed for AUGIB at the index endoscopy.	up to 28 days	Yes
Other	Need for surgery or radiological intervention to control bleeding		up to 28 days	Yes
Other	Proportion of patients experiencing the composite endpoint of thromboembolic and ischaemic events up to Day 28	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.	up to 28 days	Yes
Other	Acute Transfusion reactions up to death/ discharge	Defined as a reaction occurring at any time up to 24 hours following a transfusion of a blood component.	up to 28 days	Yes
Other	Infections	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.	up to 28 days	Yes
Other	Length of hospital stay		up to 28 days	Yes
Other	Health related quality of life at Day 28		28 days	No
Primary	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	No
Secondary	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	Yes