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Status unknownNCT01298050SEACUpdated Aug 4, 2011

Refractory IHCA and OHCA Treated With ECMO

An observational study in Cardiac Arrest, sponsored by University of Milano Bicocca. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-08-04.

Sponsored by University of Milano Bicocca · Observational

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Cardiac Arrest

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03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 382 observational studies indexed under Heart Arrest.

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Lead sponsor

University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults 18-75 years old, community sample

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • Extracorporeal Membrane Oxygenation

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

    Procedure: ECMO

Interventions

  • ProcedureECMO

    Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

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What researchers measure

Primary outcomes

  1. 28 days survival

    Time frame: 28 days

Secondary outcomes

  1. Neurologic recovery

    Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.

    Time frame: 28 days

  2. Cardiac recovery

    Measured by echocardiography

    Time frame: 28 days

  3. Six months survival with minimal neurologic impairment

    survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.

    Time frame: 180 days

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Study locations

1 of 1 sites recruiting
  • San Gerardo Hospital
    Monza, MB 20052, Italy
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01298050
Lead sponsor
University of Milano Bicocca
Collaborators
Ospedale San Gerardo. S.S.U.E.M. 118 Brianza, Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica
First posted
Feb 17, 2011
Start date
Jul 2011
Primary completion
Jul 2012 (estimated)
Completion
Jul 2013 (estimated)
Last update
Aug 4, 2011

Study contacts

Leonelllo Avalli, MD
principal investigator · Ospedale San Gerardo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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