NCT03270683

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 2, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

August 29, 2017

Last Update Submit

December 26, 2019

Conditions

Cardiac Arrest

Keywords

Out-of-hospital cardiac arresttranscranial Doppler sonographycerebrovascular circulationprognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Measurement of pulsatility index

    12 hours

  • Entry of doppler parameters

    6 months

Eligibility Criteria

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

Patients resuscitated from out-of-hospital cardiac arrest

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Adel Maamar, Dr

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 1, 2017

Study Start

May 2, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations

FR(1)