Blood Management During ECMO for Cardiac Support

NCT03714048 | Completed

• 1 other identifier: HREC/18/SVH/202
• Study Type: observational
• Target: 561
• Locations: 1 country
• Sites: 1

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.

Conditions

Death, Sudden, Cardiac; HEART ARREST; Shock, Cardiogenic; Arrhythmias, Cardiac; Hemorrhage; Venous Thrombosis; Embolism; Blood Transfusion; Disseminated Intravascular Coagulation

Keywords

Extracorporeal Membrane Oxygenation; ECMO; VA-ECMO

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Fraction of patients not surviving the index hospital admission

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

Secondary Outcomes (6)

• ECMO free days

  28 days after the start of the treatment

• ICU free days

  28 days after the start of the treatment

• Ventilator free days

  28 days after the start of the treatment

• Anticoagulation management

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

• Hemorrhagic complications

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

Study Arms (4)

Perioperative

Cardiogenic shock minus arrest

Cardiogenic shock plus arrest

Preventive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All prospective patients who receive ECMO for cardiac support in a participating centre.

You may qualify if:

• ECMO for mechanical circulatory support
• ECMO using a temporary device containing an oxygenator and an active blood pump.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (1)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Related Publications (8)

• 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.

  PMID: 29198832 RESULT

• 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.

  PMID: 29084499 RESULT

• 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.

  PMID: 28264702 RESULT

• 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.

  PMID: 28082026 RESULT

• 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.

  PMID: 27832552 RESULT

• 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.

  PMID: 25655210 RESULT

• 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.

  PMID: 24588439 RESULT

• Thao LTP, Buscher H, Nguyen TL, Martucci G, Gratz J, Trummer G, Schmidt M, Gautier M, Serra A, Takeda K, Pooth JS, Rahn K, Geismann F, Lubnow M, Retter A, Nair P, Vlok R, Siriwardena M, Winearls J, Walsham J, Gattas D, Aneman A, Fulcher B, Newman S, Reynolds C, Arcadipane A, Shekar K, Hodgson C, Pellegrino V, Mueller T, Brodie D, McQuilten Z; International ECMO Network (ECMONet). Liberal or restrictive transfusion for veno-arterial extracorporeal membrane oxygenation patients: a target trial emulation using the OBLEX study data. Crit Care. 2025 Aug 18;29(1):360. doi: 10.1186/s13054-025-05606-1.

  PMID: 40826421 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Arrest; Shock, Cardiogenic; Arrhythmias, Cardiac; Hemorrhage; Venous Thrombosis; Embolism; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis; Shock; Thrombosis; Embolism and Thrombosis; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 22, 2018
• Study Start: July 1, 2019
• Primary Completion: January 15, 2023
• Study Completion: April 15, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)