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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01638416




Registration number
NCT01638416
Ethics application status
Date submitted
9/07/2012
Date registered
11/07/2012

Titles & IDs
Public title
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
Scientific title
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
Secondary ID [1] 0 0
ANZICRCDJC006
Universal Trial Number (UTN)
Trial acronym
TRANSFUSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transfusion 0 0
Age of Blood 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Blood transfusion

Active comparator: Standard of care - Blood Transfusion Standard of care- oldest blood.

Other: Arm B - Blood Transfusion Freshest blood.


Other interventions: Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality at Day 90
Timepoint [1] 0 0
90 Day
Secondary outcome [1] 0 0
Mortality at Day 28
Timepoint [1] 0 0
28 day
Secondary outcome [2] 0 0
Persistent Organ Dysfunction Combined With Death Measured at Day 28
Timepoint [2] 0 0
day 28
Secondary outcome [3] 0 0
Days Alive and Free of Mechanical Ventilation
Timepoint [3] 0 0
day 28
Secondary outcome [4] 0 0
Day Alive and Free of Renal Replacement Therapy.
Timepoint [4] 0 0
day 28
Secondary outcome [5] 0 0
Blood Stream Infection in ICU (Post Randomisation)
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Length of Stay in ICU and in Hospital Post Randomisation (Days)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation
Timepoint [8] 0 0
Day 180

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (see below)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
4994
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Albury Hospital - Albury
Recruitment hospital [6] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [7] 0 0
Logan Hospital - Brisbane
Recruitment hospital [8] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [9] 0 0
Mater Private Hospital - Brisbane
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [12] 0 0
Calvary Health - Canberra
Recruitment hospital [13] 0 0
Canberra Hospital - Canberra
Recruitment hospital [14] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [15] 0 0
Geelong Hospital - Geelong
Recruitment hospital [16] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [17] 0 0
Gosford Hospital - Gosford
Recruitment hospital [18] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [19] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [20] 0 0
Cabrini Hospital - Melbourne
Recruitment hospital [21] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [22] 0 0
Knox Private Hospital - Melbourne
Recruitment hospital [23] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [24] 0 0
Northern Hospital - Melbourne
Recruitment hospital [25] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [26] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [27] 0 0
Sunshine Hospital - Melbourne
Recruitment hospital [28] 0 0
Western Hospital - Melbourne
Recruitment hospital [29] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [30] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [31] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [32] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [33] 0 0
St John of God Murdoch Hospital - Perth
Recruitment hospital [34] 0 0
Epworth Hospital - Richmond
Recruitment hospital [35] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [36] 0 0
Nepean Hospital - Sydney
Recruitment hospital [37] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [38] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [39] 0 0
St George Hospital - Sydney
Recruitment hospital [40] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [41] 0 0
Tamworth Hospital - Tamworth
Recruitment hospital [42] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Albury
Recruitment postcode(s) [4] 0 0
- Bendigo
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Canberra
Recruitment postcode(s) [7] 0 0
- Dandenong
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment postcode(s) [9] 0 0
- Gold Coast
Recruitment postcode(s) [10] 0 0
- Gosford
Recruitment postcode(s) [11] 0 0
- Heidelberg
Recruitment postcode(s) [12] 0 0
- Hobart
Recruitment postcode(s) [13] 0 0
- Melbourne
Recruitment postcode(s) [14] 0 0
- Newcastle
Recruitment postcode(s) [15] 0 0
- Perth
Recruitment postcode(s) [16] 0 0
- Richmond
Recruitment postcode(s) [17] 0 0
- Sydney
Recruitment postcode(s) [18] 0 0
- Tamworth
Recruitment postcode(s) [19] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Tampere
Country [3] 0 0
Ireland
State/province [3] 0 0
Cork
Country [4] 0 0
Ireland
State/province [4] 0 0
Dublin
Country [5] 0 0
Ireland
State/province [5] 0 0
Galway
Country [6] 0 0
Ireland
State/province [6] 0 0
Limerick
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
New Zealand
State/province [9] 0 0
Dunedin
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
New Zealand
State/province [11] 0 0
Nelson
Country [12] 0 0
New Zealand
State/province [12] 0 0
Wellington
Country [13] 0 0
Saudi Arabia
State/province [13] 0 0
Riyadh

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Red Cross
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
New Zealand Blood Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Irish Blood Transfusion Service
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Finnish Red Cross Blood Service
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
King Abdulaziz Medical City
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University College Dublin
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
D. James Cooper, A.O., M.D.
Address 0 0
Monash University/Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01638416