Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23939351
Publication citations
-
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.