Extracorporeal Membrane Oxygenation (ECMO): Blood Cells

June 21, 2023 updated by: Renzo Loyaga Rendon, Spectrum Health Hospitals

Extracorporeal Membrane Oxygenation: Blood Cells

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

371

Contacts and Locations

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

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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
No intervention. Blood specimen collection.
Other: Blood specimen collection
Control
No intervention. Blood specimen collection.
Other: Blood specimen collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Spectrum Health Hospitals

Collaborators

Van Andel Research Institute

Investigators

  • Principal Investigator: Renzo Loyaga-Rendon, MD,PhD, Spectrum Health Hospitals

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)

January 20, 2015

Primary Completion (Actual)

April 25, 2023

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimated)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-255

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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