Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
TRANSFUSE
A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
1 other identifier
interventional
4,994
5 countries
60
Brief Summary
In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2012
Longer than P75 for phase_3
60 active sites
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 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
October 22, 2020
CompletedOctober 22, 2020
October 1, 2020
4.5 years
July 9, 2012
June 24, 2020
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality at Day 90
Mortality at Day 90
90 Day
Secondary Outcomes (8)
Mortality at Day 28
28 day
Persistent Organ Dysfunction Combined With Death Measured at Day 28
day 28
Days Alive and Free of Mechanical Ventilation
day 28
Day Alive and Free of Renal Replacement Therapy.
day 28
Blood Stream Infection in ICU (Post Randomisation)
While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)
- +3 more secondary outcomes
Study Arms (2)
Standard of care
ACTIVE COMPARATORBlood Transfusion Standard of care- oldest blood.
Arm B
OTHERBlood Transfusion Freshest blood.
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.
You may not qualify if:
- Age younger than 18
- Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
- Diagnosis of transplantation or hematologic diseases
- Pregnancy
- Cardiac surgery during the present hospital admission
- Expected to die imminently (\<24hrs)
- The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
- Known objection to the administration of human blood products
- Participation in a competing study (see below)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Australian and New Zealand Intensive Care Research Centrelead
- Australian Red Crosscollaborator
- New Zealand Blood Servicecollaborator
- Irish Blood Transfusion Servicecollaborator
- Finnish Red Cross Blood Servicecollaborator
- King Abdulaziz Medical Citycollaborator
- University College Dublincollaborator
Study Sites (60)
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Lyell McEwin Hospital
Adelaide, Australia
Queen Elizabeth Hospital
Adelaide, Australia
Royal Adelaide Hospital
Adelaide, Australia
Albury Hospital
Albury, Australia
Bendigo Hospital
Bendigo, Australia
Logan Hospital
Brisbane, Australia
Mater Adult Hospital
Brisbane, Australia
Mater Private Hospital
Brisbane, Australia
Princess Alexandra Hospital
Brisbane, Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Calvary Health
Canberra, Australia
Canberra Hospital
Canberra, Australia
Dandenong Hospital
Dandenong, Australia
Geelong Hospital
Geelong, Australia
Gold Coast Hospital
Gold Coast, Australia
Gosford Hospital
Gosford, Australia
Austin Hospital
Heidelberg, Australia
Royal Hobart Hospital
Hobart, Australia
Cabrini Hospital
Melbourne, Australia
Frankston Hospital
Melbourne, Australia
Knox Private Hospital
Melbourne, Australia
Monash Medical Centre
Melbourne, Australia
Northern Hospital
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
St Vincent's Hospital
Melbourne, Australia
Sunshine Hospital
Melbourne, Australia
Western Hospital
Melbourne, Australia
Calvary Mater Newcastle
Newcastle, Australia
John Hunter Hospital
Newcastle, Australia
Fiona Stanley Hospital
Perth, Australia
Royal Perth Hospital
Perth, Australia
St John of God Murdoch Hospital
Perth, Australia
Epworth Hospital
Richmond, Australia
Blacktown Hospital
Sydney, Australia
Nepean Hospital
Sydney, Australia
Prince of Wales Hospital
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
St George Hospital
Sydney, Australia
St Vincent's Hospital
Sydney, Australia
Tamworth Hospital
Tamworth, Australia
Wollongong Hospital
Wollongong, Australia
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
Galway Regional Hospital
Galway, Ireland
Limerick Regional Hospital
Limerick, Ireland
Auckland City Hospital CVICU
Auckland, New Zealand
Auckland City Hospital DCCM
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Nelson Hospital
Nelson, New Zealand
Wellington Hospital
Wellington, New Zealand
King Abdulaziz Medical City
Riyadh, Saudi Arabia
Related Publications (4)
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: 38780066DERIVEDCooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, McArthur C, Murray L, Pettila V, French C; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults. N Engl J Med. 2017 Nov 9;377(19):1858-1867. doi: 10.1056/NEJMoa1707572. Epub 2017 Sep 27.
PMID: 28952891DERIVEDKaukonen KM, Bailey M, Ady B, Aubron C, French C, Gantner D, Irving D, Murray L, Nichol A, Pettila V, McQuilten Z, Cooper DJ. A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan. Crit Care Resusc. 2014 Dec;16(4):255-61.
PMID: 25437218DERIVEDKekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
PMID: 23874777DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The red-cell age in each treatment group was not prespecified but was determined by the blood-bank inventory at each institution. We did not design the trial to assign red cells toward the end of their shelf life (35 to 42 days).
Results Point of Contact
- Title
- Dr. Cooper
- Organization
- Australian and New Zealand Intensive Care Research Centre
Study Officials
- PRINCIPAL INVESTIGATOR
D. James Cooper, A.O., M.D.
Monash University/Alfred Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Two staff not involved in the direct care of each patient checked the red-cell units, and concealed the collection and expiry dates from clinical staff using a bag with opaque panels (Australia, Ireland and Saudi Arabia), or an obscuring sticker (NZ and Finland).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2017
Study Completion
June 1, 2017
Last Updated
October 22, 2020
Results First Posted
October 22, 2020
Record last verified: 2020-10