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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02863250

Registration number

NCT02863250

Ethics application status

Date submitted

27/07/2016

Date registered

11/08/2016

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]

APP1074654

Universal Trial Number (UTN)

Trial acronym

ANZ-MTR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Massive Transfusion

Trauma

Cardiothoracic Surgery

Gastrointestinal Bleeding

Vascular Surgery

Obstetric Bleeding

Liver Transplant

Condition category

Condition code

Oral and Gastrointestinal

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]

Mortality

Timepoint [1]

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?

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]

Monash University - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

Monash University

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

CSL Behring

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

Department of Health and Human Services Victoria

Address [2]

Country [2]

Other collaborator category [3]

Other

Name [3]

National Blood Authority

Address [3]

Country [3]

Other collaborator category [4]

Other

Name [4]

New Zealand Blood Service

Address [4]

Country [4]

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/study/NCT02863250

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Erica Wood, MBBS

Address

Monash University

Country

Phone

Fax

Contact person for public queries

Name

Erica Wood, MBBS

Address

Country

Phone

1800 811 326

Fax

[email protected]

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02863250

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02863250