NCT04039594

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

5 years

First QC Date

July 30, 2019

Last Update Submit

August 4, 2019

Conditions

Cardiogenic ShockCardiac Arrest

Keywords

extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    30 days

Secondary Outcomes (5)

  • All-cause mortality

    365 days

  • Rate of successful weaning from ECMO

    30 days

  • ECMO-related complications

    30 days

  • Other complications

    30 days

  • Duration stay at ICU and hospital

    365 days

Study Arms (1)

ECMO

Device: VA ECMO

Interventions

VA ECMODEVICE

VA ECMO for cardiopulmonary support

ECMO

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving VA ECMO for cardiopulmonary support

You may qualify if:

  • Patients receiving VA ECMO for cardiopulmonary support

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicHeart Arrest

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Xiaotong Hou, MD., PhD.

CONTACT

8610 64456631xt.hou@ccmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Center for Cardiac Intensive Care

Study Record Dates

First Submitted

July 30, 2019

First Posted

July 31, 2019

Study Start

August 1, 2019

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

CN(1)