NCT00944112

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

July 21, 2009

Last Update Submit

March 7, 2011

Conditions

Intensive CareBlood TransfusionAnemia

Keywords

Intensive careBlood TransfusionAnemia

Outcome Measures

Primary Outcomes (1)

  • Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups.

    60 days following randomisation

Secondary Outcomes (3)

  • assessment of complication rate in two treatment arms

    60 days following randomisation

  • assessment of length of stay in ICU and hospital

    60 days following randomisation

  • Long term follow-up to determine survival status and assess mobility, quality of life & use of health services

    60 and 180 days following randomisation

Study Arms (2)

Restrictive RBC Transfusion Group

EXPERIMENTAL

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

Liberal RBC Transfusion Group

EXPERIMENTAL

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

Interventions

Restrictive RBC TransfusionBIOLOGICAL

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.

Also known as: Restrictive Arm
Restrictive RBC Transfusion Group
Liberal RBC TransfusionBIOLOGICAL

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.

Also known as: Liberal Arm
Liberal RBC Transfusion Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ninewells Hospital & Medical School

Dundee, DD1 9SY, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 2SA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Stirling Royal Infirmary

Stirling, FK8 2AU, United Kingdom

Location

Related Publications (9)

  • 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. doi: 10.1097/CCM.0b013e3181844677.

    PMID: 18679112BACKGROUND

  • 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. doi: 10.1056/NEJM199902113400601.

    PMID: 9971864BACKGROUND

  • 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. doi: 10.1007/s00134-005-2855-2. Epub 2005 Nov 23.

    PMID: 16328221BACKGROUND

  • 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. doi: 10.1002/14651858.CD002042.

    PMID: 12076437BACKGROUND

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

    PMID: 38780066DERIVED

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PMID: 34932836DERIVED

  • Jiwaji Z, Nunn KP, Conway-Morris A, Simpson AJ, Wyncoll D, Rossi AG, Walsh TS; RELIEVE Trial Investigators. Leukoreduced blood transfusion does not increase circulating soluble markers of inflammation: a randomized controlled trial. Transfusion. 2014 Oct;54(10):2404-11. doi: 10.1111/trf.12669. Epub 2014 May 5.

    PMID: 24796937DERIVED

  • 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; RELIEVE Investigators. Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial. Crit Care Med. 2013 Oct;41(10):2354-63. doi: 10.1097/CCM.0b013e318291cce4.

    PMID: 23939351DERIVED

Related Links

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Timothy S Walsh, MBChB MD MSc

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

GB(6)