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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2020
Source Monash University
Contact Erica Wood, MBBS
Phone 1800 811 326
Email sphpm.mtr@monash.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Locations

Country Name City State
Australia Monash University Melbourne Victoria

Sponsors (5)

Lead Sponsor Collaborator
Monash University CSL Behring, Department of Health and Human Services Victoria, National Blood Authority, New Zealand Blood Service

Country where clinical trial is conducted

Australia, 

Outcome

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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