Transfusion in Gastrointestinal Bleeding (TRIGGER)
ISRCTN | ISRCTN85757829 |
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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
Scientific
NHS Blood and Transplant
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9BQ
United Kingdom
Study information
Study design | Randomised interventional pilot study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
Secondary outcome measures | 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. |
Overall study start date | 01/09/2012 |
Completion date | 01/02/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | UK Sample Size: 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
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom
OX3 9BQ
United Kingdom
Sponsor information
NHS Blood and Transplant Research & Development (UK)
Research organisation
Research organisation
National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
United Kingdom
Website | http://www.nhsbt.nhs.uk/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.