Transfusion in Gastrointestinal Bleeding (TRIGGER)

ISRCTN	ISRCTN85757829
DOI	https://doi.org/10.1186/ISRCTN85757829
ClinicalTrials.gov (NCT)	NCT02105532
Protocol serial number	12078
Sponsor	NHS Blood and Transplant Research & Development (UK)
Funder	NHS Blood and Transplant [NHSBT] (UK)

Submission date: 25/07/2012
Registration date: 26/07/2012
Last edited: 29/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vipul Jairath
Scientific

NHS Blood and Transplant
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9BQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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 acronym	TRIGGER
Study objectives	Acute upper gastrointestinal bleeding (AUGIB) accounts for 14% of all red blood cell (RBC) transfusions in England. In 2007, a large UK national audit of AUGIB highlighted areas of variation and uncertainty in RBC transfusion practice together with signals of harm associated with more liberal use of RBCs, justifying the need for a randomised controlled trial (RCT) to answer a key area of clinical uncertainty. TRIGGER is a pragmatic cluster randomised feasibility trial aiming to recruit adult patients admitted to hospital with all cause AUGIB. The study will take place in six UK hospitals and each hospital will be randomised to a transfusion policy; three sites will be randomised to a restrictive transfusion policy and three to a liberal transfusion policy. Both transfusion policies are used by doctors and hospitals in the UK already as part of routine care in the management of AUGIB and are within the limits of local hospital, national and international guidelines. Each cluster will agree to follow the transfusion policy for all eligible patients admitted with AUGIB for a total of 6 months at each site. Consent will be sought from an appropriate "guardian" of the cluster and individual participants for use of data collection and Day 28 telephone follow up. Given the challenges involved in early recruitment and cross-specialty care of patients, a feasibility study is essential to both justify and inform the design of a phase III trial.
Ethics approval(s)	First MREC 20/04/2012, ref: 12/SC/0062
Health condition(s) or problem(s) studied	Non-malignant haematology
Intervention	Transfusion Policies: The trial will compare two different policies for RBC transfusion, 'restrictive' and 'liberal'. Restrictive transfusion policy: Patients in hospitals allocated to this group will receive a transfusion if their Hb level is =8 g/dL. The objective for the attending clinician is then to maintain the Hb level between 8.1-10 g/dL Liberal transfusion policy: Patients in hospitals allocated to this group will receive a transfusion if their Hb level is =10 g/dL. The objective for the attending cl; Follow Up Length: 1 month(s)
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Protocol adherence 2. Selection bias 3. Recruitment rate 4. Red cell exposure 5. Information to inform the sample size of the phase III trial Clinical Outcomes: Further bleeding up to Day 28: Further bleeding is a composite outcome that includes persistent bleeding
Key secondary outcome measure(s)	1. Further bleeding 2. 28-day mortality 3. Infections 4. Ischaemic/thromboembolic events We will also collect data to guide a Health Economic evaluation for the phase III trial.
Completion date	01/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	849
Key inclusion criteria	1. Adults aged = 18 years presenting with AUGIB, defined by haematemesis or melaena. 2. >20 admissions with AUGIB per month 3. >400 hospital beds 4. Availability of 24 hours endoscopy and on-site access to intensive care and surgical support 5. Institutional agreement to transfuse all eligible new admissions with AUGIB in accordance with the randomised transfusion policy 6. Male & female participants 7. Lower Age Limit 18 years
Key exclusion criteria	1. Patients for whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Haemoglobin (Hb) result due to severity of bleeding (these patients should be managed according to the hospital's massive transfusion protocol or clinician discretion) 2. Existing hospital inpatients who develop an AUGIB
Date of first enrolment	01/09/2012
Date of final enrolment	01/02/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9BQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/04/2015		Yes	No
Results article	results	11/07/2015		Yes	No
Protocol article	protocol	01/07/2013		Yes	No
Other publications	strategies	21/11/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	statistical analysis plan	10/07/2013		No	No

Editorial Notes

29/08/2019: ClinicalTrials.gov number added.