Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03714048




Registration number
NCT03714048
Ethics application status
Date submitted
16/10/2018
Date registered
22/10/2018

Titles & IDs
Public title
Blood Management During ECMO for Cardiac Support
Scientific title
International Observational Study on BLood Management for Mechanical Circulatory Support Using Extracorporeal Membrane Oxygenation (OBLEX)
Secondary ID [1] 0 0
HREC/18/SVH/202
Universal Trial Number (UTN)
Trial acronym
OBLEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Death, Sudden, Cardiac 0 0
HEART ARREST 0 0
Shock, Cardiogenic 0 0
Arrhythmias, Cardiac 0 0
Hemorrhage 0 0
Venous Thrombosis 0 0
Embolism 0 0
Blood Transfusion 0 0
Disseminated Intravascular Coagulation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Perioperative -

Cardiogenic shock minus arrest -

Cardiogenic shock plus arrest -

Preventive -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital mortality
Timepoint [1] 0 0
Till the end of the index hospital admission, on average 30 days
Secondary outcome [1] 0 0
ECMO free days
Timepoint [1] 0 0
28 days after the start of the treatment
Secondary outcome [2] 0 0
ICU free days
Timepoint [2] 0 0
28 days after the start of the treatment
Secondary outcome [3] 0 0
Ventilator free days
Timepoint [3] 0 0
28 days after the start of the treatment
Secondary outcome [4] 0 0
Anticoagulation management
Timepoint [4] 0 0
For 7 days after the start of ECMO or till the end of treatment (whatever comes first)
Secondary outcome [5] 0 0
Hemorrhagic complications
Timepoint [5] 0 0
For 7 days after the start of ECMO or till the end of treatment (whatever comes first)
Secondary outcome [6] 0 0
Thromboembolic complications
Timepoint [6] 0 0
For 7 days after the start of ECMO or till the end of treatment (whatever comes first)

Eligibility
Key inclusion criteria
* ECMO for mechanical circulatory support
* ECMO using a temporary device containing an oxygenator and an active blood pump.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* ECMO for respiratory support only
* Age<18
* ECMO treatment outside the participating centre for >24 hours
* Previous enrolment in OBLEX during the same hospital admission
* ECMO treatment outside the intensive care unit only (e.g. theatre or angiography)
* Enrolment in other studies where a randomized intervention is targeting anticoagulation or blood management.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/04/2023
Sample size
Target
Accrual to date
Final
561
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03714048