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NCT04039594 Clinical Trial

Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

Cardiac Arrest Clinical Trial

Official title:
Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04039594
Other study ID # 2019027X
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date July 31, 2025

Study information
Verified date August 2019
Source Beijing Anzhen Hospital
Contact Xiaotong Hou, MD., PhD.
Phone 8610 64456631
Email xt.hou@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Venoarterial extracorporeal membrane oxygenation (VA ECMO)—also referred to as extracorporeal life support—is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 31, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• VA ECMO
VA ECMO for cardiopulmonary support

Locations
Country Name City State
China Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality 30 days
Secondary All-cause mortality 365 days
Secondary Rate of successful weaning from ECMO 30 days
Secondary ECMO-related complications Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change 30 days
Secondary Other complications Acute renal failure, ulcer bleeding, pneumonia, sepsis 30 days
Secondary Duration stay at ICU and hospital 365 days
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