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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02863250
Registration number
NCT02863250
Ethics application status
Date submitted
27/07/2016
Date registered
11/08/2016
Date last updated
2/09/2020
Titles & IDs
Public title
Australian and New Zealand Massive Transfusion Registry
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Scientific title
Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion
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Secondary ID [1]
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APP1074654
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Universal Trial Number (UTN)
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Trial acronym
ANZ-MTR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Massive Transfusion
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Trauma
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Cardiothoracic Surgery
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Gastrointestinal Bleeding
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Vascular Surgery
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Obstetric Bleeding
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0
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Liver Transplant
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Massively transfused patients - Patients (18+ years) who have had a critical bleeding event that necessitated a massive transfusion (defined as 5 or more units of red cells in any 4 hour period)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
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Timepoint [1]
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30 days
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Eligibility
Key inclusion criteria
- aged 18 years or over
- 5 or more units of red blood cells in any 4 hour period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- nil
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
50000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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CSL Behring
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Address [1]
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0
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Department of Health and Human Services Victoria
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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National Blood Authority
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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New Zealand Blood Service
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
Severe and un-stopped blood loss can occur for a number of different reasons including after
a serious injury, delivery of a baby and following other medical and surgical emergencies.
The investigators understanding of how to best treat people with serious bleeding is still
incomplete, with many questions remaining. These include questions regarding how many people
have serious bleeding events, what happens to them and the best way to treat them.
The Massive Transfusion Registry (MTR) is a register of patients who have experienced major
blood loss that required a massive transfusion in any clinical setting.
The MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical
data from hospital data sources, including Laboratory Information Systems (for transfusion
history and laboratory results) and Health Information Services databases (for Patient
demographics and admission data), are electronically extracted by staff employed at the
participating hospitals. The data is then sent to the MTR Research Team, located at Monash
University, where it is then linked, analysed and stored.
The establishment of a Massive Transfusion Registry will be a unique and important resource
for clinicians in Australia, New Zealand and internationally, for Blood Services and for the
broader community. It will provide valuable observational data regarding the types and
frequency of conditions associated with critical bleeding requiring massive transfusion, the
use of blood component therapy (i.e. ratios and quantities of different types of red cell to
non- red cell components) and patient outcomes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02863250
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Erica Wood, MBBS
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Erica Wood, MBBS
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Address
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Country
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Phone
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1800 811 326
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02863250
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