Restrictive and Liberal Transfusion Strategies in Intensive Care (RELIEVE)

Completed

• Conditions: Anaemia; Intensive Care; Blood Transfusion; Surgery

• Registration Number: ISRCTN24842715
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Assessment of the complication rate in the two treatment arms: data on the following will be collected from medical records at 60 days.<br>1.1. organ failures<br>1.2. acute coronary syndromes<br>1.3. thromboembolic and cerebrovascular events<br>1.4. number of ventilation and antimicrobial free days <br>2. Assessment of length of stay in ICU and hospital. Data collected from medical records.<br>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.<br>3.1. Rivermead Mobility Index<br>3.2. Quality of Life questionnaire (SF12v2)<br>3.3. Health Economic questionnaire (6 month follow-up only)