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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02042898




Registration number
NCT02042898
Ethics application status
Date submitted
17/01/2014
Date registered
23/01/2014

Titles & IDs
Public title
Transfusion Requirements in Cardiac Surgery III
Scientific title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Secondary ID [1] 0 0
301852
Secondary ID [2] 0 0
TRICSIII
Universal Trial Number (UTN)
Trial acronym
TRICS-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorder; Heart, Functional, Postoperative, Cardiac Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Restrictive transfusion strategy - Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is \<75 g/L (\<7.5 g/dL;\<4.7mmol/L) intraoperatively and/or postoperatively

Active comparator: Liberal transfusion strategy - Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is \<95 g/L (\<9.5 g/dL\<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or \<85 g/L (\< 8.5 g/dL;\<5.3mmol/L) on the ward.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit
Timepoint [1] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [1] 0 0
Incidence of in-hospital all-cause mortality
Timepoint [1] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [2] 0 0
Incidence of in-hospital myocardial infarction
Timepoint [2] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [3] 0 0
Incidence of in-hospital new renal failure requiring dialysis
Timepoint [3] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [4] 0 0
Incidence of in-hospital new focal neurological deficit
Timepoint [4] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [5] 0 0
Length of stay in the ICU and hospital
Timepoint [5] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [6] 0 0
Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device
Timepoint [6] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [7] 0 0
Duration of mechanical ventilation
Timepoint [7] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [8] 0 0
Incidence of infection
Timepoint [8] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [9] 0 0
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
Timepoint [9] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [10] 0 0
Incidence of gut infarction
Timepoint [10] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [11] 0 0
The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization)
Timepoint [11] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [12] 0 0
Death
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
New onset dialysis (since incident surgery) status
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Stroke
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
Coronary revascularization
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Myocardial infarction
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Health Care Utilization
Timepoint [17] 0 0
6 months
Secondary outcome [18] 0 0
Renal function, based on changes in postoperative serum creatinine
Timepoint [18] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [19] 0 0
Incidence of Seizures
Timepoint [19] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [20] 0 0
Incidence of Encephalopathy
Timepoint [20] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [21] 0 0
Incidence of Delirium
Timepoint [21] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)

Eligibility
Key inclusion criteria
* Age 18 or older
* Planned cardiac surgery using cardiopulmonary bypass
* Informed consent obtained
* Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who are unable to receive or who refuse blood products
* Patients who are involved in a preoperative autologous pre-donation program
* Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
* Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
* Patients who are unable to receive or who refuse blood products

Study design
Purpose of the study
Other
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
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
20/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
5028
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Cabrini Health - Malvern
Recruitment hospital [10] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Barwon Health (University Hospital Geelong) - Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3220 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Newfoundland and Labrador
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
Colombia
State/province [17] 0 0
Santander
Country [18] 0 0
Colombia
State/province [18] 0 0
Bogota
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Egypt
State/province [20] 0 0
Tanta
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Giessen
Country [23] 0 0
Greece
State/province [23] 0 0
Volos
Country [24] 0 0
India
State/province [24] 0 0
Karnataka
Country [25] 0 0
India
State/province [25] 0 0
Gujarat
Country [26] 0 0
Israel
State/province [26] 0 0
Ramat Gan
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lampur
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
New Zealand
State/province [31] 0 0
Dunedin
Country [32] 0 0
New Zealand
State/province [32] 0 0
Hamilton
Country [33] 0 0
New Zealand
State/province [33] 0 0
Wellington
Country [34] 0 0
Romania
State/province [34] 0 0
Târgu-Mure?
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
South Africa
State/province [36] 0 0
KwaZulu-Natal
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Switzerland
State/province [40] 0 0
Basel
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Unity Health Toronto
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
David Mazer, MD
Address 0 0
Unity Health Toronto
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02042898