NCT02748668

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 20, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

8.6 years

First QC Date

April 19, 2016

Last Update Submit

June 3, 2024

Conditions

Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    1 year

Study Arms (2)

ECMO

No intervention. Blood specimen collection.

Other: Blood specimen collection

Control

No intervention. Blood specimen collection.

Other: Blood specimen collection

Interventions

Blood specimen collectionOTHER
ControlECMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Subject is less than 18 years of age
  • Known prisoner
  • Control Subjects:
  • Greater than 18 years of age
  • Without any known cardiovascular, lung, or autoimmune disease.
  • Less than or equal to 18 years of age
  • Known cardiovascular, lung, or autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood is collected for analysis of cytokines and inflammatory cell patterns, and will be stored for future research.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Renzo Loyaga-Rendon, MD,PhD

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Cardiovascular Research

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 22, 2016

Study Start

January 20, 2015

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

US(1)