Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
NCT ID: NCT01638416
Last Updated: 2020-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4994 participants
INTERVENTIONAL
2012-10-31
2017-06-30
Brief Summary
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Detailed Description
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•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.
Exclusion criteria
* 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
Primary outcome- 90 day mortality
Secondary outcomes
1. 28 day mortality
2. Persistent Organ Dysfunction combined with death at 28
3. Days alive and free of mechanical ventilation at day 90 post randomisation
4. Day alive and free of renal replacement therapy at day 90 post randomisation
5. Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria
6. Length of stay in ICU and in hospital post randomisation
7. Febrile non-haemolytic transfusion reactions
8. EQ-5D score at Day 90 post randomisation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard of care
Blood Transfusion Standard of care- oldest blood.
Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Arm B
Blood Transfusion Freshest blood.
Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Interventions
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Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Australian Red Cross
OTHER
New Zealand Blood Service
OTHER
Irish Blood Transfusion Service
OTHER
Finnish Red Cross Blood Service
OTHER
King Abdulaziz Medical City
OTHER_GOV
University College Dublin
OTHER
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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David James Cooper
Professor
Principal Investigators
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D. James Cooper, A.O., M.D.
Role: PRINCIPAL_INVESTIGATOR
Monash University/Alfred Hospital
Locations
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The Alfred Hospital
Melbourne, Victoria, 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
Countries
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References
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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.
Cooper 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.
Kaukonen 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.
Kekre 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ANZICRCDJC006
Identifier Type: -
Identifier Source: org_study_id
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