ECMO: Optimization of Its Use | NCT02280460

Studies
ECMO: Optimization of Its Use

NCT02280460

Sponsor

Renzo Loyaga Rendon

Status

Terminated

Last Update Posted

Jun 5, 2024Actual

Enrollment

921Actual

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation Complication

Interventions

Not provided

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

Sep 2014

Primary Completion Date

May 29, 2024Actual

Completion Date

May 29, 2024Actual

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 2014Estimated

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
Corewell Health West	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

To create a local registry for ECMO patients.

Detailed Description

To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.

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

921Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VA ECMO		Patients who are placed on VA ECMO.
VV ECMO		Patients who are placed on VV ECMO.

Interventions

Not provided

Measure	Description	Time Frame
All cause mortality		1 year

Measure	Description	Time Frame
all cause mortality		48 hours
In-house mortality		30 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age<18
Known prisoner of the state

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

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

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
490805	Background	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.
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