Restrictive and Liberal Transfusion Strategies in Intensive Care - Full Text View

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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation

U.S. FDA Resources

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

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:

Edinburgh Clinical Trials Unit website This link exits the ClinicalTrials.gov site

Publications:

Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008 Sep;36(9):2667-74. Review.

Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056.

Walsh TS, Lee RJ, Maciver CR, Garrioch M, Mackirdy F, Binning AR, Cole S, McClelland DB. Anemia during and at discharge from intensive care: the impact of restrictive blood transfusion practice. Intensive Care Med. 2006 Jan;32(1):100-9. Epub 2005 Nov 23.

Hill SR, Carless PA, Henry DA, Carson JL, Hebert PC, McClelland DB, Henderson KM. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2002;(2):CD002042. Review.

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

Additional relevant MeSH terms:

Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on June 13, 2013

Restrictive and Liberal Transfusion Strategies in Intensive Care (RELIEVE)