NCT01298050

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

February 16, 2011

Last Update Submit

August 3, 2011

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • 28 days survival

    28 days

Secondary Outcomes (3)

  • Neurologic recovery

    28 days

  • Cardiac recovery

    28 days

  • Six months survival with minimal neurologic impairment

    180 days

Study Arms (1)

Extracorporeal Membrane Oxygenation

All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.

Procedure: ECMO

Interventions

ECMOPROCEDURE

Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

Extracorporeal Membrane Oxygenation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 18-75 years old, community sample

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gerardo Hospital

Monza, MB, 20052, Italy

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Leonelllo Avalli, MD

    Ospedale San Gerardo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2013

Last Updated

August 4, 2011

Record last verified: 2011-07

Locations

IT(1)