Restrictive and Liberal Transfusion Strategies in Intensive Care (RELIEVE)

This study has been completed.
Sponsor:
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Transfusion Medicine Education and Research Foundation
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00944112
First received: July 21, 2009
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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 RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

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

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Condition Intervention
Intensive Care
Blood Transfusion
Anemia
Biological: Restrictive RBC Transfusion
Biological: Liberal RBC Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

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. [ Time Frame: 60 days following randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assessment of complication rate in two treatment arms [ Time Frame: 60 days following randomisation ] [ Designated as safety issue: Yes ]
  • assessment of length of stay in ICU and hospital [ Time Frame: 60 days following randomisation ] [ Designated as safety issue: No ]
  • Long term follow-up to determine survival status and assess mobility, quality of life & use of health services [ Time Frame: 60 and 180 days following randomisation ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Restrictive RBC Transfusion Group
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70g/L with a target Hb concentration of 71-90g/L during the intervention period.
Biological: Restrictive RBC Transfusion
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.
Other Name: Restrictive Arm
Experimental: Liberal RBC Transfusion Group
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90g/L with a target Hb concentration of 91-110g/L during the intervention period.
Biological: Liberal RBC Transfusion
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target Hb concentration of 91-110 g/L during intervention.
Other Name: Liberal Arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient with active bleeding at the time of screening
  • Patient with traumatic brain injury as presenting diagnosis
  • Patient with intracranial haemorrhage as presenting diagnosis
  • Patient not expected to survive the next 48 hours at the time of assessment.
  • Patient objects to RBC transfusion
  • Patient receiving concurrent treatment with erythropoietin or similar erythropoietic agent
  • Follow up is not feasible
  • Already enrolled in another RCT with similar clinical endpoints
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944112

Locations
United Kingdom
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 2SA
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
St Thomas' Hospital
London, United Kingdom, SE1 7EH
The Royal London Hospital
London, United Kingdom, E1 1BB
Stirling Royal Infirmary
Stirling, United Kingdom, FK8 2AU
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Chief Scientist Office of the Scottish Government
Transfusion Medicine Education and Research Foundation
Investigators
Principal Investigator: Timothy S Walsh, MBChB MD MSc NHS Lothian
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gemma Watson, The University of Edinburgh
ClinicalTrials.gov Identifier: NCT00944112     History of Changes
Other Study ID Numbers: CZB/4/698, UK Clinical Research Network, ISRCTN Register
Study First Received: July 21, 2009
Last Updated: March 7, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Intensive care
Blood Transfusion
Anemia

ClinicalTrials.gov processed this record on October 23, 2014