NCT02832895

Brief Summary

Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA). The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined. The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.

Trial Health

57
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

July 12, 2016

Last Update Submit

January 17, 2018

Conditions

Acute Brain Injury

Keywords

AdultsFrontal bone windowTranscranial doppler

Outcome Measures

Primary Outcomes (1)

  • measures of ACA flow velocities threw the frontal bone window

    up to 72 hours

Study Arms (1)

Transcranial Doppler examination

EXPERIMENTAL

Transcranial Doppler examination

Other: Transcranial doppler examination

Interventions

Transcranial doppler examinationOTHER

Assessment of frontal bone window for transcranial doppler

Transcranial Doppler examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Membership in a health insurance scheme
  • Patients with an acute cerebral pathology
  • Hospitalized patients in a supportive care unit of Montpellier University Hospital
  • Be able to benefit from transcranial doppler within 3 days of admission

You may not qualify if:

  • Clinical suspicion of encephalic death
  • Known allergy to ultrasound gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Camille CM Maury, MD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

July 1, 2015

Primary Completion

September 30, 2016

Study Completion

December 30, 2016

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

FR(1)