Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

August 4, 2019 updated by: Xiaotong Hou, Beijing Anzhen Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Xiaotong Hou, MD., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving VA ECMO for cardiopulmonary support

Description

Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMO
Device: VA ECMO
VA ECMO for cardiopulmonary support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2025

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 4, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019027X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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