Massive TransfusionANZ-MTRNCT02863250
Australian and New Zealand Massive Transfusion Registry
An observational study of Massive Transfusion and Trauma, run by Monash University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massive Transfusion, Trauma, Cardiothoracic Surgery
- How many people
- 50,000 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged 18 years or over
- 5 or more units of red blood cells in any 4 hour period
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Monash University
Melbourne, Victoria, 3004
Souheir Houssami, PHD, +61 3 990 52052, muhrec@monash.edu
About this study
Official title: Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion
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.
Read more
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.
Read the detailed description
The Australian and New Zealand Massive Transfusion Registry (ANZ-MTR) Clinical Dataset brings together data from multiple sources and analyses and reports contemporary information on transfusion practice and patient outcomes following critical bleeding (CB) and massive transfusion (MT) in all clinical settings, including surgery, trauma, obstetrics and gastrointestinal bleeding. Data on more than 6,000 patients from 25 participating sites have already been collected, analysed and results shared with participants.
The ANZ-MTR is a unique resource. Recognising the valuable dataset available for transfusion policy and practice improvement, the ANZ-MTR is now transitioning from primarily a research tool to a sustainable operational model to align with Australia's national safety and quality framework, whilst still allowing research opportunities.
ANZ-MTR data are already linked with the Australian and New Zealand National Death Indexes and the ANZ-MTR team is engaged with establishing linkages with other registries (e.g. intensive care, cardiothoracic surgery, trauma, maternity outcomes and others). This will provide expanded data for more sensitive outcome measurement.
The ANZ-MTR uses electronic data extraction and data linkage methodologies. 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 the participating hospitals. The data are then sent to the ANZ-MTR, located at Monash University, where the data from the separate information systems are linked to enable detailed analyses that otherwise would not be easily possible. Monash University's Department of Epidemiology and Preventive Medicine, where the ANZ-MTR is located, has internationally recognised expertise in the management and statistical analyses of large, complex electronic datasets.
- Conditions
- Massive Transfusion, Trauma, Cardiothoracic Surgery, Gastrointestinal Bleeding, Vascular Surgery, Obstetric Bleeding
- Medical subject headings
- Wounds and Injuries, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMar 2011
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring, Department of Health and Human Services Victoria, National Blood Authority, New Zealand Blood Service
- Responsible party
- Principal investigator, Erica Wood, Monash University
- Investigators
- Erica Wood, MBBS, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863250
- Sponsor's protocol ID
- APP1074654
- Acronym
- ANZ-MTR
- Status last verified
- Aug 2020
- First submitted
- 27 Jul 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion
- ClinicalTrials.gov ID
- NCT02863250
- Acronym / sponsor ID
- ANZ-MTR / APP1074654
- Conditions
- Massive Transfusion, Trauma, Cardiothoracic Surgery, Gastrointestinal Bleeding, Vascular Surgery, Obstetric Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- CSL Behring, Department of Health and Human Services Victoria, National Blood Authority, New Zealand Blood Service
- Study start
- Mar 2011
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Australian and New Zealand Massive Transfusion Registry (ANZ-MTR) Clinical Dataset brings together data from multiple sources and analyses and reports contemporary information on transfusion practice and patient outcomes following critical bleeding (CB) and massive transfusion (MT) in all clinical settings, including surgery, trauma, obstetrics and gastrointestinal bleeding. Data on more than 6,000 patients from 25 participating sites have already been collected, analysed and results shared with participants.
The ANZ-MTR is a unique resource. Recognising the valuable dataset available for transfusion policy and practice improvement, the ANZ-MTR is now transitioning from primarily a research tool to a sustainable operational model to align with Australia's national safety and quality framework, whilst still allowing research opportunities.
ANZ-MTR data are already linked with the Australian and New Zealand National Death Indexes and the ANZ-MTR team is engaged with establishing linkages with other registries (e.g. intensive care, cardiothoracic surgery, trauma, maternity outcomes and others). This will provide expanded data for more sensitive outcome measurement.
The ANZ-MTR uses electronic data extraction and data linkage methodologies. 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 the participating hospitals. The data are then sent to the ANZ-MTR, located at Monash University, where the data from the separate information systems are linked to enable detailed analyses that otherwise would not be easily possible. Monash University's Department of Epidemiology and Preventive Medicine, where the ANZ-MTR is located, has internationally recognised expertise in the management and statistical analyses of large, complex electronic datasets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- aged 18 years or over
- 5 or more units of red blood cells in any 4 hour period
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erica Wood, MBBS principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Massive Transfusion and Trauma, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Wood, MBBS (1800 811 326, sphpm.mtr@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.