Trauma Clinical Trial
— ANZ-MTROfficial title:
Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion
NCT number | NCT02863250 |
Other study ID # | APP1074654 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2011 |
Est. completion date | December 31, 2028 |
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.
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - aged 18 years or over - 5 or more units of red blood cells in any 4 hour period Exclusion Criteria: - nil |
Country | Name | City | State |
---|---|---|---|
Australia | Monash University | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Monash University | CSL Behring, Department of Health and Human Services Victoria, National Blood Authority, New Zealand Blood Service |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood product use | Trends in blood products transfused at 48 hours across various bleeding types | 48 hours | |
Primary | Mortality | 30 days |
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