Restrictive and Liberal Transfusion Strategies in Intensive Care (RELIEVE)
| ISRCTN | ISRCTN24842715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24842715 |
| ClinicalTrials.gov number | NCT00944112 |
| Secondary identifying numbers | CZB/4/698; UKCRN ID 6606 |
- Submission date
- 24/11/2009
- Registration date
- 03/12/2009
- Last edited
- 12/12/2013
- 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
Prof Timothy Walsh
Scientific
Scientific
Intensive Care Unit
Edinburgh Royal Infirmary
Little France Crescent
Edinburgh
EH16 2SA
United Kingdom
| Phone | +44 (0)131 242 3208 |
|---|---|
| Timothy.Walsh@ed.ac.uk |
Study information
| Study design | Multicentre single blind randomised controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.clinicaltrials.ed.ac.uk/trials/relieve/resources/Patient_Information_Sheet_(Scotland).pdf |
| Scientific title | A feasibility randomised trial comparing restrictive and liberal blood transfusion strategies in patients requiring four or more days in intensive care (ICU) |
| Study acronym | RELIEVE |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2009 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Intensive Care Unit
Edinburgh
EH16 2SA
United Kingdom
EH16 2SA
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Old College
South Bridge
Edinburgh
Edinburgh
EH8 9YL
Scotland
United Kingdom
| Phone | +44 (0)131 650 1000 |
|---|---|
| communications.office@ed.ac.uk | |
| Website | http://www.ed.ac.uk |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
Chief Scientist Office (UK) (ref: CZB/4/698)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Additional support has been provided by the Transfusion Medicine Education and Research Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
