Condition category
Surgery
Date applied
24/11/2009
Date assigned
03/12/2009
Last edited
12/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.clinicaltrials.ed.ac.uk/trials/relieve

Contact information

Type

Scientific

Primary contact

Prof Timothy Walsh

ORCID ID

Contact details

Intensive Care Unit
Edinburgh Royal Infirmary
Little France Crescent
Edinburgh
EH16 2SA
United Kingdom
+44 (0)131 242 3208
Timothy.Walsh@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00944112

Protocol/serial number

CZB/4/698; UKCRN ID 6606

Study information

Scientific title

A feasibility randomised trial comparing restrictive and liberal blood transfusion strategies in patients requiring four or more days in intensive care (ICU)

Acronym

RELIEVE

Study hypothesis

The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term.
The aim of this study is to test the hypothesis that liberal use of red blood cells (RBCs) (Hb transfusion trigger less than or equal to 90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger less than or equal to 70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (4 days or more).

Further reading:
1. http://www.ncbi.nlm.nih.gov//pubmed/18679112
2. http://www.ncbi.nlm.nih.gov//pubmed/9971864
3. http://www.ncbi.nlm.nih.gov//pubmed/16328221
4. http://www.ncbi.nlm.nih.gov//pubmed/12076437

For further information, please visit www.eccrg.org.uk

Ethics approval

1. Primary ethics approval received from the Scotland A Research Ethics Committee on the 8th of May 2009 (ref: 09/MRE00/24)
2. English ethics approval received from the Leeds (West) Research Ethics Committee on the 17th of August 2009 (ref: 09/H1307/66)

Study design

Multicentre single blind randomised controlled feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.clinicaltrials.ed.ac.uk/trials/relieve/resources/Patient_Information_Sheet_(Scotland).pdf

Condition

Anaemia; Blood Transfusion; Intensive Care

Intervention

Added to record on 29th November 2010. Follow-up completed, study now closed.

Added to record 21/06/2010: Recruitment completed on 5th May 2010, study currently in follow-up phase.

Participants will be randomised to one of two treatment arms; restrictive or liberal. Outcome measures of the two groups will be compared.

Restrictive RBC Transfusion
Patients will receive single unit RBC transfusions with a transfusion trigger of 70 g/L or less with a target Hb concentration of 71-90 g/L during the intervention period.

Liberal RBC Transfusion
Patients will receive single unit RBC transfusions with a transfusion trigger of 90 g/L or less with a target Hb concentration of 91-110 g/L during the intervention period.

The intervention period in both treatment arms will last a minimum of 14 days or until discharge from the intensive care unit, whichever is longer. Participants will be followed up for a 6 month period from the date of randomisation.

Joint Sponsor Details
Lothian University Hospitals Division
Research & Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Phone: 0131 242 3330
Fax: 0131 242 3343
email: R&DOffice@luht.scot.nhs.uk

Study Centres
Chief Investigator: Prof. Timothy S Walsh
Royal Infirmary of Edinburgh
Edinburgh

Principal Investigator: Dr Charles Wallis
Western General Hospital
Edinburgh

Principal Investigator: Dr Chris Cairns
Stirling Royal Infirmary
Stirling

Principal Investigator: Dr Stephen Cole
Ninewells Hospital & Medical School
Dundee

Principal Investigator: Dr Rupert Pearse
The Royal London Hospital
London

Principal Investigator: Dr Duncan Wyncoll
St Thomas' Hospital
London

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups.
Data will be collected from the medical records at the end of the intervention period or at 60 days.

Secondary outcome measures

1. Assessment of the complication rate in the two treatment arms: data on the following will be collected from medical records at 60 days.
1.1. organ failures
1.2. acute coronary syndromes
1.3. thromboembolic and cerebrovascular events
1.4. number of ventilation and antimicrobial free days
2. Assessment of length of stay in ICU and hospital. Data collected from medical records.
3. Long term follow-up to determine survival status and assess mobility, quality of life & use of health services. Data collected using the following questionnaires which will be sent at 2 and 6 months.
3.1. Rivermead Mobility Index
3.2. Quality of Life questionnaire (SF12v2)
3.3. Health Economic questionnaire (6 month follow-up only)

Overall trial start date

01/08/2009

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. The patient remains in the ICU after 96 hours (4 days) or more following ICU admission
2. The patient has required mechanical ventilation via an endotracheal tube or tracheostomy tube for 96 hours or more
3. The patient is expected to require 24 hours or more of further mechanical ventilation at the time of assessment
4. The patient is aged 55 years of age or older
5. The patient has a Hb value of 90g/L or less at the time of assessment

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patient with active bleeding at the time of screening
2. Patient with traumatic brain injury as presenting diagnosis
3. Patient with intracranial haemorrhage as presenting diagnosis
4. Patient not expected to survive the next 48 hours at the time of assessment.
5. Patient objects to RBC transfusion
6. Patient receiving concurrent treatment with erythropoietin or similar erythropoietic agent
7. Follow up is not feasible
8. Already enrolled in another RCT with similar clinical endpoints

Recruitment start date

01/08/2009

Recruitment end date

01/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Intensive Care Unit
Edinburgh
EH16 2SA
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

Old College
South Bridge
Edinburgh
Edinburgh
EH8 9YL
United Kingdom
+44 (0)131 650 1000
communications.office@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) (ref: CZB/4/698)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

Additional support has been provided by the Transfusion Medicine Education and Research Foundation (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 results in: http://www.ncbi.nlm.nih.gov/pubmed/23939351

Publication citations

  1. Results

    Walsh TS, Boyd JA, Watson D, Hope D, Lewis S, Krishan A, Forbes JF, Ramsay P, Pearse R, Wallis C, Cairns C, Cole S, Wyncoll D, , Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial., Crit. Care Med., 2013, 41, 10, 2354-2363, doi: 10.1097/CCM.0b013e318291cce4.

Additional files

Editorial Notes