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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

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]

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

HEART ARREST

Shock, Cardiogenic

Arrhythmias, Cardiac

Hemorrhage

Venous Thrombosis

Embolism

Blood Transfusion

Disseminated Intravascular Coagulation

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Cardiovascular

Other cardiovascular diseases

Blood

Clotting disorders

Cardiovascular

Coronary heart disease

Blood

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]

Hospital mortality

Timepoint [1]

Till the end of the index hospital admission, on average 30 days

Secondary outcome [1]

ECMO free days

Timepoint [1]

28 days after the start of the treatment

Secondary outcome [2]

ICU free days

Timepoint [2]

28 days after the start of the treatment

Secondary outcome [3]

Ventilator free days

Timepoint [3]

28 days after the start of the treatment

Secondary outcome [4]

Anticoagulation management

Timepoint [4]

For 7 days after the start of ECMO or till the end of treatment (whatever comes first)

Secondary outcome [5]

Hemorrhagic complications

Timepoint [5]

For 7 days after the start of ECMO or till the end of treatment (whatever comes first)

Secondary outcome [6]

Thromboembolic complications

Timepoint [6]

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?

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]

St Vincent's Hospital - Sydney

Recruitment postcode(s) [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

Type	Citations or Other Details
Journal	Buscher H, Hayward C. Extracorporeal Membrane Oxyg... [More Details]
Journal	Buscher H, Zhang D, Nair P. A pilot, randomised co... [More Details]
Journal	Smith M, Vukomanovic A, Brodie D, Thiagarajan R, R... [More Details]
Journal	Buscher H, Vukomanovic A, Benzimra M, Okada K, Nai... [More Details]
Journal	Venkatesh K, Nair PS, Hoechter DJ, Buscher H. Curr... [More Details]
Journal	Nair P, Hoechter DJ, Buscher H, Venkatesh K, Whitt... [More Details]
Journal	Herbert DG, Buscher H, Nair P. Prolonged venovenou... [More Details]

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

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