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Completed

NCT Number: NCT03270683

Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest

Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography (TCD) in comatose survivors after cardiac arrest.

Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit and cardiac intensive care unit in a university hospital.

Patients: all comatose patients older than 18 years successfully resuscitated from an out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic brain injury, no window for TCD measurements, or dead before neurological prognostication are excluded.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes

Rennes, France

About this study

The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the right and left middle cerebral artery during the first 12 h after return of spontaneous circulation (ROSC). The highest value of DFV and the lowest of PI will use for the statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital discharge.

Data provided by early TCD after ROSC are associated with neurological outcome. The use of these data could lead to the development of therapeutics improving cerebral perfusion in patient resuscitated from an OHCA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older 18 years
  • out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity

Exclusion criteria

  • transcranial doppler not done or not interpretable
  • associated cranial trauma
  • died without neurological assessment

Treatment and study plan

Primary outcomes

  1. Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge

    Time frame: 6 months

    Good score = CPC 1-2 and bad score = CPC 3-5

Secondary outcomes

  1. Measurement of pulsatility index

    Time frame: 12 hours

    Evaluate the association between pulsatility index and period of cardiac arrest

  2. Entry of doppler parameters

    Time frame: 6 months

    Identify a doppler parameter than can improve the neurological outcome

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest: the DOTAC Study

Acronym: DOTAC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2017
Registry last updated
Dec 27, 2019

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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