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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03270683
Other study ID # 35RC16_3047_DOTAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2016
Est. completion date October 2017

Study information

Verified date December 2019
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge Good score = CPC 1-2 and bad score = CPC 3-5 6 months
Secondary Measurement of pulsatility index Evaluate the association between pulsatility index and period of cardiac arrest 12 hours
Secondary Entry of doppler parameters Identify a doppler parameter than can improve the neurological outcome 6 months
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