Condition category
Surgery
Date applied
25/07/2012
Date assigned
26/07/2012
Last edited
04/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vipul Jairath

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12078

Study information

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.

Acronym

TRIGGER

Study hypothesis

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

First MREC 20/04/2012, ref: 12/SC/0062

Study design

Randomised interventional pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2012

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 849

Participant 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

Recruitment start date

01/09/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom

Sponsor information

Organisation

NHS Blood and Transplant Research & Development (UK)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.nhsbt.nhs.uk/

Funders

Funder type

Research organisation

Funder name

NHS Blood and Transplant [NHSBT] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23706959
2013 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/23837630
2014 strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25416527
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25926146
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25956718

Publication citations

  1. Protocol

    Jairath V, Kahan BC, Gray A, Doré CJ, Mora A, Dyer C, Stokes EA, Llewelyn C, Bailey AA, Dallal H, Everett SM, James MW, Stanley AJ, Church N, Darwent M, Greenaway J, Le Jeune I, Reckless I, Campbell HE, Meredith S, Palmer KR, Logan RF, Travis SP, Walsh TS, Murphy MF, Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: rationale and protocol for a cluster randomized feasibility trial., Transfus Med Rev, 2013, 27, 3, 146-153, doi: 10.1016/j.tmrv.2013.04.001.

  2. Statistical analysis plan

    Kahan BC, Jairath V, Murphy MF, Doré CJ, Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial., Trials, 2013, 14, 206, doi: 10.1186/1745-6215-14-206.

  3. Results

    HE Campbell, EA Stokes, D Bargo, RF Logan, A Mora, R Hodge, A Gray, MW James, AJ Stanley, SM Everett, AA Bailey, H Dallal, J Greenaway, C Dyer, C Llewelyn, TS Walsh, SPL Travis, MF Murphy, V Jairath on behalf of TRIGGER investigators, Costs and quality of life associated with acute upper gastrointestinal bleeding in the UK: cohort analysis of patients in a cluster randomised trial , BMJ Open, 2015, 5, e007230, doi: 10.1136/bmjopen-2014-007230 .

  4. Results

    Jairath V, Kahan BC, Gray A, Doré CJ, Mora A, James MW, Stanley AJ, Everett SM, Bailey AA, Dallal H, Greenaway J, Le Jeune I, Darwent M, Church N, Reckless I, Hodge R, Dyer C, Meredith S, Llewelyn C, Palmer KR, Logan RF, Travis SP, Walsh TS, Murphy MF, Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial, Lancet, 2015 , 386, 9989, 137-144, doi: 10.1016/S0140-6736(14)61999-1.

  5. Results

    Kahan BC, Cro S, Doré CJ, Bratton DJ, Rehal S, Maskell NA, Rahman N, Jairath V, Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials, Trials, 2014, 15, 456, doi: 10.1186/1745-6215-15-456.

Additional files

Editorial Notes