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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03714048
Ethics application status
Date submitted
16/10/2018
Date registered
22/10/2018
Date last updated
19/09/2019

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 - Fraction of patients not surviving the index hospital admission
Timepoint [1] 0 0
Till the end of the index hospital admission, on average 30 days
Secondary outcome [1] 0 0
ECMO free days - Number of days alive and not treated with ECMO during the first 28 days after the start of the treatment
Timepoint [1] 0 0
28 days after the start of the treatment
Secondary outcome [2] 0 0
ICU free days - Number of days alive and not treated in ICU during the first 28 days after the start of the treatment
Timepoint [2] 0 0
28 days after the start of the treatment
Secondary outcome [3] 0 0
Ventilator free days - Number of days alive and not treated with mechanical ventilation during the first 28 days after the start of the treatment
Timepoint [3] 0 0
28 days after the start of the treatment
Secondary outcome [4] 0 0
Anticoagulation management - Parameter used to titrate anticoagulation, drug used and achieved values
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 - Type, location and management of hemorrhage
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 - Type, location and management of thromboembolic complication
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Extracorporeal membrane oxygenation (ECMO) is a lifesaving procedure used to treat severe
forms of heart and/or lung failure. It works by the principal of replacing the function of
these organs by taking blood from the patient, provide it with oxygen outside the body and
return it to the patient in one continuous circuit. Because of the evaluability of better
technology, the use of ECMO has exponentially risen over the last decade. This treatment is
very invasive and carries a number of risks. It is mostly used in situations where it seems
likely that the patient would otherwise die and no other less invasive measure could change
this. Still in large registries 50-60% of patients die which is often due to complications
associated with the treatment.

One of the most important complication is caused by the activation of clotting factors during
the contact with the artificial surfaces of the device. This can lead to clot formation
inside the patient or the device. To counterbalance this anticoagulation is needed. Because
of the consumption of clotting factors and the heparin therapy bleeding complications are
also very common in ECMO.

Clinicians are challenged to balance these competing risks and are often forced to transfuse
blood products to treat these conditions, which comes with additional risks for the patient.
Many experienced centres have reported thromboembolic and bleeding events as the most
important contributor to a poor outcome of this procedure. However, no international study
combining the experience of multiple centres to compare their practice and identify risk
factors which can be altered to reduce these risks.

This study has been endorsed by the international ECMONet and aims to observe the practice in
up to 50 centres and 500 patients worldwide to generate the largest ever published database
on this topic. It will concentrate on patients with severe heart failure and will be able to
identify specific risk factors for thromboembolic and bleeding events. Some of these factors
may be modifiable by change in practice and can subsequently be evaluated in clinical trials.
Some of these factors may include target values for heparin therapy and infusion of clotting
factors.

This study will directly improve patient management by informing clinicians which measures
are associated with the best outcome and indirectly helps building trials to increase the
evidence further.
Trial website
https://clinicaltrials.gov/show/NCT03714048
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
Hergen Buscher, Dr
Address 0 0
Country 0 0
Phone 0 0
+61283821111
Fax 0 0
Email 0 0
hergen.buscher@svha.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03714048