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| Name | Class |
|---|---|
| Australian Red Cross | OTHER |
| New Zealand Blood Service | OTHER |
| Irish Blood Transfusion Service | OTHER |
| Finnish Red Cross Blood Service |
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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.
Inclusion criteria
•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
Primary outcome- 90 day mortality
Secondary outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Blood Transfusion Standard of care- oldest blood. |
|
| Arm B | Other | Blood Transfusion Freshest blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood transfusion | Other | Blood transfusion in ICU patients aged 18 and over. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at Day 90 | Mortality at Day 90 | 90 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at Day 28 | Mortality at day 28 | 28 day |
| Persistent Organ Dysfunction Combined With Death Measured at Day 28 | Persistent Organ Dysfunction combined with death measured at day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. James Cooper, A.O., M.D. | Monash University/Alfred Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia | ||
| Lyell McEwin Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38780066 | Derived | 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. | |
| 28952891 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm B (Short Term Storage) | Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over. |
| FG001 | Standard of Care (Long-term Storage) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2014 |
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| OTHER |
| King Abdulaziz Medical City | OTHER_GOV |
| University College Dublin | OTHER |
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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).
| day 28 |
| Days Alive and Free of Mechanical Ventilation | Days alive and free of mechanical ventilation | day 28 |
| Day Alive and Free of Renal Replacement Therapy. | Day alive and free of renal replacement therapy. | day 28 |
| Blood Stream Infection in ICU (Post Randomisation) | Blood stream infection in ICU (post randomisation) Time Frame is in Days | 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) |
| Length of Stay in ICU and in Hospital Post Randomisation (Days) | Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days | Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3) |
| Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU | 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) |
| EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet | Day 180 |
| 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 |
| Derived |
| 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. |
| 25437218 | Derived | 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. |
| 23874777 | Derived | 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. |
Blood Transfusion Standard of care- oldest blood.
Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm B (Short Term Storage) | Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over. |
| BG001 | Standard of Care (Long Term Storage) | Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| APACHE III | The APACHE III score consists of several parts including the primary reason for ICU admission, age, sex, race, pre existing comorbidities, and location prior to ICU admission. The range of APACHE III score is from 0 to 299 points. APACHE III is widely used to assess illness severity of patients admitted to ICU and to compare risk-adjusted outcomes between ICUs. Increasing score is associated with increasing risk of hospital death. A score of 0 is associated with a very low risk of death | Median | Standard Deviation | units on a scale |
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| ABO Blood group | Count of Participants | Participants |
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| Haemoglobin at Admission to ICU | Median | Standard Deviation | g/liter |
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| Haemoglobin at randomisation | Median | Standard Deviation | g/liter |
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| SOFA Score | The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score was calculated on admission. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patient. The SOFA score ranges from 0-24. A score of 0 predicts a very good outcome. A score of 24 predicts a very poor patient outcome | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality at Day 90 | Mortality at Day 90 | Pre specified Sub groups | Posted | Number | participants | 90 Day |
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| Secondary | Mortality at Day 28 | Mortality at day 28 | Posted | Count of Participants | Participants | 28 day |
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| Secondary | Persistent Organ Dysfunction Combined With Death Measured at Day 28 | Persistent Organ Dysfunction combined with death measured at day 28 | Posted | Count of Participants | Participants | day 28 |
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| |||||||||||||||||||||||||||||||
| Secondary | Days Alive and Free of Mechanical Ventilation | Days alive and free of mechanical ventilation | Posted | Median | Inter-Quartile Range | days | day 28 |
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| Secondary | Day Alive and Free of Renal Replacement Therapy. | Day alive and free of renal replacement therapy. | Posted | Median | Inter-Quartile Range | days | day 28 |
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| ||||||||||||||||||||||||||||||
| Secondary | Blood Stream Infection in ICU (Post Randomisation) | Blood stream infection in ICU (post randomisation) Time Frame is in Days | Posted | Count of Participants | Participants | 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) |
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| Secondary | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days | Posted | Median | Inter-Quartile Range | Days | Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3) |
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| Secondary | Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU | Posted | Count of Participants | Participants | 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) |
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| Secondary | EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet | Not Posted | Jul 2022 | Day 180 | Participants |
Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization.
We defined a febrile nonhemolytic transfusion reaction as occurring when a patient had an unexpected increase in temperature of 1°C or more within 4 hours after transfusion in the absence of other pyretic stimuli.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm B (Short Term Storage) | Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over. | 687 | 2,410 | 0 | 2,457 | 158 | 2,457 |
| EG001 | Standard of Care (Long Term Storage) | Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over. | 678 | 2,414 | 0 | 2,462 | 127 | 2,462 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Nonhaemolytic transfusion reaction | Immune system disorders | Systematic Assessment |
| ||
| New Bloodstream Infection in ICU | Blood and lymphatic system disorders | Systematic Assessment |
|
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).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cooper | Australian and New Zealand Intensive Care Research Centre | +61 3 9903 0071 | 30071 | anzicrc@monash.edu |
| Aug 5, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2013 | Aug 5, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Group O |
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| Non-Group O |
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| APACHE III risk of Death <21.5% |
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| APACHE III risk of Death =or>21.5% |
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| Baseline SOFA score = or < 7 |
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| Baseline SOFA score >7 |
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