Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000736044
Ethics application status
Approved
Date submitted
30/08/2010
Date registered
3/09/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of allocating the freshest available red blood cells to critically ill patients: a pilot study
Scientific title
Critically ill patients receiving freshest available red blood cells compared to standard care feasibility study
Secondary ID [1] 252602 0
NIL
Universal Trial Number (UTN)
U1111-1116-7679
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood transfusion in critically ill 258086 0
Condition category
Condition code
Public Health 258266 258266 0 0
Epidemiology
Blood 258275 258275 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transfusion of freshest available red blood cells. The freshest red blood cell is defined by the shortest number of days between the collection of the blood and its delivery.
The freshest available red blood cells will be take in the back of the fridge of the blood bank
The patients receiving the freshest red blood cells will be allocated in this group after randomisation
This allocation remains throughout the stay in intensive care or for the study period (6weeks)
The methods used in transfusion, the amoount of blood transfused depend on the needs of the patients and on the doctor's prescription. These characteristics are not defined by the protocole.
Intervention code [1] 257115 0
Treatment: Other
Comparator / control treatment
standard care - blood of standard age
The standard care is the transfusion of the oldest available red blood cell, which has the highest number of days between the collection and the delivery (maximum 42 days).
Control group
Active

Outcomes
Primary outcome [1] 259107 0
the primary aim of this study is to determine feasibility of allocating the freshest available red blood cells in critically ill patients.
We will calculate the percentage of patients randomized among the eligible patients. The good communication between the intensive care unit-team and the blood bank team. and we will calculate the percentage of red blood cell packs younger than 7 days in each study group.
Timepoint [1] 259107 0
At the end of the 6 week study period
Primary outcome [2] 259115 0
the primary aim of this study is to determine feasibility of allocating the freshest available red blood cells in critically ill patients
Timepoint [2] 259115 0
At the end of the 6 week study period
Secondary outcome [1] 265413 0
The median age of all RBC units received by the freshest red blood cells (RBC) unit group will be compared to the median age of RBC units received by the standard care group
Timepoint [1] 265413 0
At the end of the 6 week study period
Secondary outcome [2] 265427 0
The median age of all RBC units received by the freshest red blood cells (RBC) unit group will be compared to the median age of RBC units received by the standard care group
Timepoint [2] 265427 0
At the end of the 6 week study period

Eligibility
Key inclusion criteria
Patients hospitalised in the intensive care unit
Age equal or higher than 18 years
Require administration of at least one red blood cells unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative care
Transplant
Oncology and Haematology patients
Patients with known red blood cells antibodies requiring antigen negative units (Patients will be withdrawn from the study if the requirement for antigen-specific red cells is identified after randomisation)

Study design
Purpose of the study
Prevention
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?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257560 0
University
Name [1] 257560 0
Monash University
Country [1] 257560 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 256786 0
None
Name [1] 256786 0
Address [1] 256786 0
Country [1] 256786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259582 0
Ethics committee address [1] 259582 0
Ethics committee country [1] 259582 0
Australia
Date submitted for ethics approval [1] 259582 0
22/04/2010
Approval date [1] 259582 0
11/08/2010
Ethics approval number [1] 259582 0
1/10/0135

Summary
Brief summary
The purpose of this study is to know if it is feasible to do a randomized controlled trial by allocating the freshest available red blood cells in critically patients, versus standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31086 0
Address 31086 0
Country 31086 0
Phone 31086 0
Fax 31086 0
Email 31086 0
Contact person for public queries
Name 14333 0
Dr Aubron Cecile
Address 14333 0
The Australian and New Zealand Intensive Care Research Centre
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 14333 0
Australia
Phone 14333 0
+61 (0)3 9903 0598
Fax 14333 0
Email 14333 0
[email protected]
Contact person for scientific queries
Name 5261 0
Dr Aubron Cecile
Address 5261 0
Senior research fellow
The Australian and New Zealand Intensive Care Research Centre
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 5261 0
Australia
Phone 5261 0
+61 (0)3 9903 0598
Fax 5261 0
Email 5261 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.