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NCT Number: NCT03594318

Versailles Hospital Cardiac Arrest Registry

Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Versailles

Le Chesnay, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiac arrest requiring Intensive Care Unit management
  • Age >= 18 years

Exclusion criteria

  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Long term favorable outcome

    Time frame: 1 year

    A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.

    The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability]

Secondary outcomes

  1. Short term favorable outcome

    Time frame: 3 months

    A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.

    The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability]

  2. Postanoxic Status Epilepticus

    Time frame: 28 days

    Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria

  3. Complications of anticoagulant/ antiplatelet therapies

    Time frame: 28 days

    Any bleeding requiring >2 Units Red Blood Cell transfusion

  4. Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)

    Time frame: 3 months

    Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).

  5. Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)

    Time frame: 1 year

    Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2026
Study completion
2030
First posted
Jul 20, 2018
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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