Hemorrhage Clinical Trial
— OBLEXOfficial title:
International Observational Study on BLood Management for Mechanical Circulatory Support Using Extracorporeal Membrane Oxygenation (OBLEX)
NCT number | NCT03714048 |
Other study ID # | HREC/18/SVH/202 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | April 15, 2023 |
Verified date | April 2023 |
Source | St Vincent's Hospital, Sydney |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 561 |
Est. completion date | April 15, 2023 |
Est. primary completion date | January 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ECMO for mechanical circulatory support - ECMO using a temporary device containing an oxygenator and an active blood pump. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | St Vincent's Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
St Vincent's Hospital, Sydney |
Australia,
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. — View Citation
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- — View Citation
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) — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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: 10.1177/03 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital mortality | Fraction of patients not surviving the index hospital admission | Till the end of the index hospital admission, on average 30 days | |
Secondary | ECMO free days | Number of days alive and not treated with ECMO during the first 28 days after the start of the treatment | 28 days after the start of the treatment | |
Secondary | ICU free days | Number of days alive and not treated in ICU during the first 28 days after the start of the treatment | 28 days after the start of the treatment | |
Secondary | Ventilator free days | Number of days alive and not treated with mechanical ventilation during the first 28 days after the start of the treatment | 28 days after the start of the treatment | |
Secondary | Anticoagulation management | Parameter used to titrate anticoagulation, drug used and achieved values | For 7 days after the start of ECMO or till the end of treatment (whatever comes first) | |
Secondary | Hemorrhagic complications | Type, location and management of hemorrhage | For 7 days after the start of ECMO or till the end of treatment (whatever comes first) | |
Secondary | Thromboembolic complications | Type, location and management of thromboembolic complication | For 7 days after the start of ECMO or till the end of treatment (whatever comes first) |
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