Trial Review

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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
Scientific title
Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion
Secondary ID [1] 0 0
APP1074654
Universal Trial Number (UTN)
Trial acronym
ANZ-MTR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Massive Transfusion 0 0
Trauma 0 0
Cardiothoracic Surgery 0 0
Gastrointestinal Bleeding 0 0
Vascular Surgery 0 0
Obstetric Bleeding 0 0
Liver Transplant 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
- aged 18 years or over

- 5 or more units of red blood cells in any 4 hour period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- nil

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
50000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
CSL Behring
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Department of Health and Human Services Victoria
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Blood Authority
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
New Zealand Blood Service
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02863250
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Erica Wood, MBBS
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Erica Wood, MBBS
Address 0 0
Country 0 0
Phone 0 0
1800 811 326
Fax 0 0
Email 0 0
sphpm.mtr@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02863250