ISRCTN ISRCTN85757829
DOI https://doi.org/10.1186/ISRCTN85757829
ClinicalTrials.gov number NCT02105532
Secondary identifying numbers 12078
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

Study designRandomised interventional pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA multi-centre, feasibility, cluster randomised controlled trial comparing restrictive versus liberal blood transfusion strategies in adult patients admitted with acute upper gastrointestinal bleeding.
Study acronymTRIGGER
Study objectivesAcute 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) studiedNon-malignant haematology
InterventionTransfusion 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 typeProcedure/Surgery
Primary outcome measure1. 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
Secondary outcome measures1. 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.
Overall study start date01/09/2012
Completion date01/02/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 849
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2012
Date of final enrolment01/02/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom

Sponsor information

NHS Blood and Transplant Research & Development (UK)
Research organisation

National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
United Kingdom

Website http://www.nhsbt.nhs.uk/
ROR logo "ROR" https://ror.org/0227qpa16

Funders

Funder type

Research organisation

NHS Blood and Transplant [NHSBT] (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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