Refractory IHCA and OHCA Treated With ECMO | NCT01298050

Studies
Refractory IHCA and OHCA Treated With ECMO

NCT01298050

Sponsor

University of Milano Bicocca

Status

Unknown status

Last Update Posted

Aug 4, 2011Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

ECMO

Countries

Italy

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

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Feb 16, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

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

Aug 3, 2011

Last Update Posted Date

Aug 4, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Milano BicoccaOTHER

Collaborators

Name	Class
Ospedale San Gerardo. S.S.U.E.M. 118 Brianza	UNKNOWN
Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extracorporeal Membrane Oxygenation		All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.	Procedure: ECMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO	Procedure	Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia	Extracorporeal Membrane Oxygenation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28 days survival		28 days

Secondary Outcomes

Measure	Description	Time Frame
Neurologic recovery	Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.	28 days
Cardiac recovery	Measured by echocardiography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults 18-75 years old
In and out of hospital Witnessed Cardiac Arrest
No-flow time < 5 min. or VF,VT,TP as rhythm of presentation
Low-flow time < 45 min.
End Tidal CO2 > 10 after 20 min.of CPR

Exclusion Criteria:

Comorbidities such:
Terminal Malignancy
Aortic Dissection
Severe Cardiac Failure without transplant indication
Severe Aortic Valve Failure
Known Severe Peripheral arteriopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adults 18-75 years old, community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonelllo Avalli, MD	Ospedale San Gerardo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Gerardo Hospital	Recruiting	Monza	MB	20052	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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