Australian and New Zealand Massive Transfusion Registry

NCT02863250 | Recruiting DMC

• 1 other identifier: APP1074654
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Massive Transfusion; Trauma; Cardiothoracic Surgery; Gastrointestinal Bleeding; Vascular Surgery; Obstetric Bleeding; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 days

Other Outcomes (1)

• Blood product use

  48 hours

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to participating hospitals, aged 18 years or over, who have had a critical bleeding event that necessitated a massive transfusion (defined as 5 or more units of red blood cells in any 4 hour period), in any clinical context.

You may qualify if:

• aged 18 years or over
• or more units of red blood cells in any 4 hour period

You may not qualify if:

• nil

Sponsors & Collaborators

• Monash University: lead
• CSL Behring: collaborator
• Department of Health and Human Services Victoria: collaborator
• National Blood Authority: collaborator
• New Zealand Blood Service: collaborator

Study Sites (1)

Monash University

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Wood, MBBS

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Wood, MBBS

CONTACT

1800 811 326; sphpm.mtr@monash.edu

Rosemary Sparrow, PhD

CONTACT

1800 811 326; sphpm.mtr@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 11, 2016
• Study Start: March 1, 2011
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)