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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
Date last updated
20/04/2023

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
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/study/NCT03714048
Trial related presentations / publications
Buscher H, Hayward C. Extracorporeal Membrane Oxygenation: An Expanding Role in Cardiovascular Care. Heart Lung Circ. 2018 Jan;27(1):3-5. doi: 10.1016/S1443-9506(17)31472-5. No abstract available.
Buscher H, Zhang D, Nair P. A pilot, randomised controlled trial of a rotational thromboelastometry-based algorithm to treat bleeding episodes in extracorporeal life support: the TEM Protocol in ECLS Study (TEMPEST). Crit Care Resusc. 2017 Oct;19(Suppl 1):29-36.
Smith M, Vukomanovic A, Brodie D, Thiagarajan R, Rycus P, Buscher H. Duration of veno-arterial extracorporeal life support (VA ECMO) and outcome: an analysis of the Extracorporeal Life Support Organization (ELSO) registry. Crit Care. 2017 Mar 6;21(1):45. doi: 10.1186/s13054-017-1633-1.
Buscher H, Vukomanovic A, Benzimra M, Okada K, Nair P. Blood and Anticoagulation Management in Extracorporeal Membrane Oxygenation for Surgical and Nonsurgical Patients: A Single-Center Retrospective Review. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):869-875. doi: 10.1053/j.jvca.2016.10.015. Epub 2016 Oct 17.
Venkatesh K, Nair PS, Hoechter DJ, Buscher H. Current limitations of the assessment of haemostasis in adult extracorporeal membrane oxygenation patients and the role of point-of-care testing. Anaesth Intensive Care. 2016 Nov;44(6):669-680. doi: 10.1177/0310057X1604400601.
Nair P, Hoechter DJ, Buscher H, Venkatesh K, Whittam S, Joseph J, Jansz P. Prospective observational study of hemostatic alterations during adult extracorporeal membrane oxygenation (ECMO) using point-of-care thromboelastometry and platelet aggregometry. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):288-96. doi: 10.1053/j.jvca.2014.06.006. Epub 2015 Feb 2.
Herbert DG, Buscher H, Nair P. Prolonged venovenous extracorporeal membrane oxygenation without anticoagulation: a case of Goodpasture syndrome-related pulmonary haemorrhage. Crit Care Resusc. 2014 Mar;16(1):69-72.
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



Summary Results

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