Outcomes of Patients With Venoarterial Extracorporeal Mem... | NCT04039594

Studies
Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

NCT04039594

Sponsor

Beijing Anzhen Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cardiogenic Shock
Cardiac Arrest

Interventions

VA ECMO

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2025Estimated

First Submitted Date

Jul 30, 2019

First Submission Date that Met QC Criteria

Jul 30, 2019

First Posted Date

Jul 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2019

Last Update Posted Date

Aug 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaotong Hou, Chief, Center for Cardiac Intensive Care, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
ECMO			Device: VA ECMO

Name	Type	Description	Arm Group Labels	Other Names
VA ECMO	Device	VA ECMO for cardiopulmonary support	ECMO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		30 days

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality		365 days
Rate of successful weaning from ECMO		30 days
ECMO-related complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients receiving VA ECMO for cardiopulmonary support

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaotong Hou, MD., PhD.	Contact	8610 64456631		xt.hou@ccmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality	100029	China

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic
D006323	Heart Arrest

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided