Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000453886
Ethics application status
Approved
Date submitted
23/04/2012
Date registered
23/04/2012
Date last updated
20/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Standard Issue Transfusion versus fresher red blood cell use in intensive care - a randomized controlled trial
Scientific title
The effect of transfusion of fresher blood versus standard care on 28 and 90 day mortality in patients admitted to ICU.
Secondary ID [1] 292445 0
ClinicalTrials.gov NCT01638416
Universal Trial Number (UTN)
Trial acronym
TRANSFUSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood transfusion 285995 0
Critically ill patients 304056 0
Condition category
Condition code
Blood 286182 286182 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: These patients will receive the freshest available group-specific compatible RBC unit in the transfusion service.
Indication,timing and number of RBC units will be determined as per standard practice by the clinician for each individual situation.
Intervention code [1] 284409 0
Treatment: Other
Comparator / control treatment
No intervention: standard of care. These patients will receive standard practice, which is the oldest available group-specific compatible RBC unit in the transfusion service.
Control group
Active

Outcomes
Primary outcome [1] 286651 0
This study aims to determine whether, compared to standard care, transfusion of the freshest available allogeneic RBC decreases mortality of patients admitted to ICU.
Timepoint [1] 286651 0
90 day mortality
Secondary outcome [1] 296382 0
Persistant Organ Dysfunction combined with death at day 28 defined as number of days requiring mechanical ventilation, renal replacement therapy and catecholamines.
Timepoint [1] 296382 0
day 28
Secondary outcome [2] 336969 0
Mortality
Timepoint [2] 336969 0
Day 28
Secondary outcome [3] 336970 0
Days alive and free of mechanical ventilation (post randomisation) at day 28
Timepoint [3] 336970 0
Day 28
Secondary outcome [4] 336971 0
Days alive and free of RRT post randomisation at day 28
Timepoint [4] 336971 0
Day 28
Secondary outcome [5] 336972 0
Blood stream infection rate in ICU post randomisation
Timepoint [5] 336972 0
While in ICU
Secondary outcome [6] 336973 0
Length of stay in ICU post randomisation
Timepoint [6] 336973 0
At ICU discharge
Secondary outcome [7] 336974 0
Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU
Timepoint [7] 336974 0
While in ICU
Secondary outcome [8] 336975 0
Quality of life (EQ5D) at 180 days
Timepoint [8] 336975 0
Day 180
Secondary outcome [9] 336976 0
Length of stay in hospital post randomisation
Timepoint [9] 336976 0
At hospital discharge

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

A 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

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)
The inclusion exclusion criteria will be checked when a clinical decision is made to transfuse. Transfusion indication, timing and number of the RBC units will be determined by the treating clinicians.

Randomisation will be performed using a web based computer system.
The patient will be allocated a unique study identification number at randomisation (to identify their study involvement for the first and each subsequent RBC transfusion during their ICU stay. This number will be recorded on a sticker placed in the patient’s chart and also on the RBC request form sent to the hospital transfusion service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatment allocation will be determined using variable block randomisation in a 1:1 ratio, stratified by centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study sample of 5000 patients will provide 90% power for a two-sided difference of 4.2% in the primary outcome of 90-day mortality between treatment groups. The baseline
mortality was estimated from a previous observational study. Patients in our study who would have been eligible for the TRANSFUSE trial had a hospital mortality of 25%. We conservatively estimate the 90-day mortality to be 28%. The sample size calculation was based on a 15% relative decrease in 90-day mortality, or an absolute decrease of 4.2% from 28% to 23.8%. With a type I error of 0.05 and a type II error of 0.1 (power 90%), the needed patient number is 2332 per group. According to previous studies, the loss to follow-up should not exceed 5%; the addition of 5% yields an accurate number of 4898 patients, which we have rounded up to 5000 patients. All analyses will be on an intention-to-treat basis, except where otherwise indicated. No imputation for missing data will be performed and the number of analysed observations will be reported. The level of significance is set to 0.05 in all analyses and P will not be adjusted for multiplicity. All analyses will be unadjusted unless otherwise specified. (See detailed description in TRANSFUSE SAP 2014 Kaukonen, Crit Care Resusc)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
14/11/2012
Date of last participant enrolment
Anticipated
Actual
1/12/2016
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
5000
Accrual to date
Final
4994
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 5228 0
2010
Recruitment postcode(s) [2] 5218 0
2031
Recruitment postcode(s) [3] 5224 0
2065
Recruitment postcode(s) [4] 5202 0
2139
Recruitment postcode(s) [5] 5194 0
2148
Recruitment postcode(s) [6] 5211 0
2170
Recruitment postcode(s) [7] 5226 0
2217
Recruitment postcode(s) [8] 5208 0
2250
Recruitment postcode(s) [9] 5198 0
2298
Recruitment postcode(s) [10] 5209 0
2305
Recruitment postcode(s) [11] 5201 0
2605
Recruitment postcode(s) [12] 5199 0
2617
Recruitment postcode(s) [13] 5189 0
2640
Recruitment postcode(s) [14] 5216 0
2750
Recruitment postcode(s) [15] 5190 0
3004
Recruitment postcode(s) [16] 5230 0
3011
Recruitment postcode(s) [17] 5223 0
3050
Recruitment postcode(s) [18] 5227 0
3065
Recruitment postcode(s) [19] 5217 0
3076
Recruitment postcode(s) [20] 5191 0
3084
Recruitment postcode(s) [21] 5195 0
3128
Recruitment postcode(s) [22] 5213 0
3135
Recruitment postcode(s) [23] 5196 0
3144
Recruitment postcode(s) [24] 5215 0
3168
Recruitment postcode(s) [25] 5203 0
3175
Recruitment postcode(s) [26] 5206 0
3220
Recruitment postcode(s) [27] 5192 0
3350
Recruitment postcode(s) [28] 5193 0
3550
Recruitment postcode(s) [29] 5221 0
4029
Recruitment postcode(s) [30] 5214 0
4101
Recruitment postcode(s) [31] 5219 0
4102
Recruitment postcode(s) [32] 5207 0
4215
Recruitment postcode(s) [33] 5229 0
4350
Recruitment postcode(s) [34] 5197 0
4870
Recruitment postcode(s) [35] 5200 0
5000
Recruitment postcode(s) [36] 5220 0
5011
Recruitment postcode(s) [37] 5204 0
5043
Recruitment postcode(s) [38] 5212 0
5112
Recruitment postcode(s) [39] 5225 0
6000
Recruitment postcode(s) [40] 5205 0
6959
Recruitment postcode(s) [41] 5222 0
7000
Recruitment postcode(s) [42] 5210 0
7250
Recruitment outside Australia
Country [1] 4185 0
New Zealand
State/province [1] 4185 0
South Island
Country [2] 4186 0
Finland
State/province [2] 4186 0
Helsinki
Country [3] 4187 0
New Zealand
State/province [3] 4187 0
North Island
Country [4] 9068 0
Ireland
State/province [4] 9068 0
Dublin
Country [5] 9069 0
Ireland
State/province [5] 9069 0
Galway
Country [6] 9070 0
Ireland
State/province [6] 9070 0
Cork
Country [7] 9071 0
Ireland
State/province [7] 9071 0
Limerick
Country [8] 9072 0
Ireland
State/province [8] 9072 0
St James
Country [9] 9073 0
Saudi Arabia
State/province [9] 9073 0
Riyadh

Funding & Sponsors
Funding source category [1] 284839 0
Government body
Name [1] 284839 0
National Health Medical Research Council
Country [1] 284839 0
Australia
Funding source category [2] 297012 0
Government body
Name [2] 297012 0
Health Research Board of Ireland
Country [2] 297012 0
Ireland
Funding source category [3] 297013 0
Government body
Name [3] 297013 0
Health Research Council of New Zealand
Country [3] 297013 0
New Zealand
Funding source category [4] 297014 0
Government body
Name [4] 297014 0
Australian Red Cross Blood Service
Country [4] 297014 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health & Preventive Medicine
Monash University
Level 3
553 St Kilda Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 296012 0
University
Name [1] 296012 0
University College Dublin
Address [1] 296012 0
Stillorgan Rd, Belfield, Dublin 4, Ireland
Country [1] 296012 0
Ireland
Other collaborator category [1] 279639 0
Government body
Name [1] 279639 0
Australian Red Cross Blood Service
Address [1] 279639 0
Optus Centre, 1/367 Collins St, Melbourne VIC 3000
Country [1] 279639 0
Australia
Other collaborator category [2] 279640 0
Government body
Name [2] 279640 0
Finnish Red Cross Blood Service
Address [2] 279640 0
Kivihaantie 7, 00310 Helsinki, Finland
Country [2] 279640 0
Finland
Other collaborator category [3] 279641 0
Government body
Name [3] 279641 0
New Zealand Blood Service
Address [3] 279641 0
11 Great South Rd, Epsom, Auckland 1050, New Zealand
Country [3] 279641 0
New Zealand
Other collaborator category [4] 279642 0
Government body
Name [4] 279642 0
Irish Blood Transfusion Service
Address [4] 279642 0
5 D'Olier Street, Dublin, Ireland
Country [4] 279642 0
Ireland
Other collaborator category [5] 279643 0
Government body
Name [5] 279643 0
King Abdulaziz Medical City blood bank
Address [5] 279643 0
Ar Rimayah, 2682, Riyadh 14611, Saudi Arabia
Country [5] 279643 0
Saudi Arabia
Other collaborator category [6] 279644 0
University
Name [6] 279644 0
University College Dublin
Address [6] 279644 0
Stillorgan Road, Belfield campus, Dublin 4
Country [6] 279644 0
Ireland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287089 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 287089 0
55 Commercial Road
Ground Floor, Linay Pavilion
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Ethics committee country [1] 287089 0
Australia
Date submitted for ethics approval [1] 287089 0
22/03/2012
Approval date [1] 287089 0
23/04/2012
Ethics approval number [1] 287089 0
81/12

Summary
Brief summary
Red blood cell (RBC) transfusion is a very common and potentially life-saving treatment in intensive care units (ICUs). However, RBC transfusion has also been associated with an increased risk of morbidity and/or mortality in critically ill, surgical and trauma patients. Although this association is multifactorial, attention has increasingly focused on the possible adverse impact of transfusing RBC which have been stored for a prolonged time.The primary aim of the trial is to determine if transfusion of the freshest available RBC in critically ill patients compared to standard care decreases patient mortality.
Trial website
http://www.anzicrc.monash.org/transfuse-rct.html
Trial related presentations / publications
Crit Care Resusc. 2014 Dec;16(4):255-61.. A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan. Kaukonen KM, Bailey M, Ady B, Aubron C, French C, Gantner D, Irving D, Murray L, Nichol A, Pettilä V, McQuilten Z, Cooper DJ.
Public notes

Contacts
Principal investigator
Name 33874 0
Prof D. James Cooper AO
Address 33874 0
ANZIC-RC
Monash University
Level 3
553 St Kilda Road
MELBOURNE VIC 3004
AUSTRALIA
Country 33874 0
Australia
Phone 33874 0
+61 (0) 3 9903 0343
Fax 33874 0
Email 33874 0
jamie.cooper@monash.edu
Contact person for public queries
Name 17121 0
Ms Bridget Ady
Address 17121 0
ANZIC-RC
Monash University
Level 3
553 St Kilda Road
MELBOURNE VIC 3004
AUSTRALIA
Country 17121 0
Australia
Phone 17121 0
+61 3 99030035
Fax 17121 0
+61 3 99030071
Email 17121 0
bridget.ady@monash.edu
Contact person for scientific queries
Name 8049 0
Ms Bridget Ady
Address 8049 0
ANZIC-RC
Monash University
Level 3
553 St Kilda Road
MELBOURNE VIC 3004
AUSTRALIA
Country 8049 0
Australia
Phone 8049 0
+61 3 99030035
Fax 8049 0
+61 3 99030071
Email 8049 0
bridget.ady@monash.edu

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan.2014
N.B. These documents automatically identified may not have been verified by the study sponsor.