NCT02280460

Brief Summary

To create a local registry for ECMO patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

9.7 years

First QC Date

October 29, 2014

Last Update Submit

June 3, 2024

Conditions

Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    1 year

Secondary Outcomes (2)

  • all cause mortality

    48 hours

  • In-house mortality

    30 day

Study Arms (2)

VA ECMO

Patients who are placed on VA ECMO.

VV ECMO

Patients who are placed on VV ECMO.

Eligibility Criteria

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

Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.

You may qualify if:

  • Age \>18
  • requiring ECMO. For the control,Patients without ECMO admited to ICU.

You may not qualify if:

  • Age\<18
  • Known prisoner of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (2)

  • Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.

    PMID: 490805BACKGROUND

  • Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.

    PMID: 19762075BACKGROUND

Study Officials

  • Renzo Loyaga-Rendon, MD,PhD

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Cardiovascular Research

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

September 1, 2014

Primary Completion

May 29, 2024

Study Completion

May 29, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

US(1)