Extracorporeal Membrane Oxygenation (ECMO): Blood Cells | NCT02748668

Studies
Extracorporeal Membrane Oxygenation (ECMO): Blood Cells

NCT02748668

Sponsor

Corewell Health West

Status

Terminated

Last Update Posted

Jun 5, 2024Actual

Enrollment

371Actual

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation

Interventions

Blood specimen collection

Countries

United States

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not able to achieve primary objective and there is no intention to work towards its achievement

Expanded Access Info

Start Date

Jan 20, 2015Actual

Primary Completion Date

Aug 23, 2023Actual

Completion Date

Aug 23, 2023Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 21, 2016

First Posted Date

Apr 22, 2016Estimated

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

Jun 3, 2024

Last Update Posted Date

Jun 5, 2024Actual

Name	Class
Van Andel Research Institute	OTHER

Description Module

Brief Summary

The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.

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

8 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

371Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECMO		No intervention. Blood specimen collection.	Other: Blood specimen collection
Control		No intervention. Blood specimen collection.	Other: Blood specimen collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood specimen collection	Other		Control ECMO

Measure	Description	Time Frame
All cause mortality		1 year

Eligibility Module

Eligibility Criteria

ECMO group:

Inclusion Criteria:

Greater than or equal to 18 years of age
Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.

Exclusion Criteria:

Subject is less than 18 years of age
Known prisoner

Control Subjects:

Inclusion Criteria

Greater than 18 years of age
Without any known cardiovascular, lung, or autoimmune disease.

Exclusion Criteria:

Less than or equal to 18 years of age
Known cardiovascular, lung, or autoimmune disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

500 patients on ECMO and 100 control patients will be enrolled into the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renzo Loyaga-Rendon, MD,PhD	Corewell Health West	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Health		Grand Rapids	Michigan	49503	United States

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

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