Phase
Condition
Brain Injury
Neurologic Disorders
Treatment
Transcranial Doppler (TCD)
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mild TBI (GCS 13-15 on ED admission) with one of the following:
Patient with minor cerebral lesion on initial CT scan (TCDBII i.e. no midline shift,visible basal cisterns and haemorrhagic lesion < 25 cc) and GCS 15 after CT scan
OR * Patient with normal initial CT scan (TCDB I) with at least one risk factor :
GCS = 14 after CT scan
and/or alcoholic intoxication
and/or on-going treatment with anticoagulants or anti-platelet therapy
and /or persisting nausea, and/or vomiting and/or headaches
Early initial CT scan (< 4 hours after TBI)
Possibility of home supervision by a third-party
Affiliation to the French social security system
Patient have signed consent form
Possibility to perform a TCD within 12 hours
Stable hemodynamics defined as a blood pressure greater than 90 mmHg, an SpO2greater than 92% and a hemoglobin concentration greater than 8g/dl, or, in theabsence of measured physiologic parameters or the absence of biological sampling,mention in the patient's medical record of a stable clinical examination in terms ofhemodynamics and respiratory function.
Exclusion
Exclusion Criteria:
CT scan classified as TCDB III - VI
Penetrating head-trauma
Patient under mechanical ventilation
Patients treated with anticoagulants or anti-platelet therapy (except Aspirin)
Hospitalization required by post-traumatic extra-cranial lesion, intoxication (except alcoholic), pre-existing condition (including congenital hemostasisdisorders) or social factors at the discretion of the physician.
Internal Carotid dissection
Post-traumatic lesion in the posterior cerebral fossa
Subject in exclusion period of another interventional study,
Pregnant women, breastfeeding women
Subject under administrative or judicial control, under protection
Study Design
Study Description
Connect with a study center
CH Bourg-en-bresse
Bourg-en-Bresse,
FranceSite Not Available
CHU Clermont-Ferrand
Clermont-Ferrand,
FranceActive - Recruiting
CHU Grenoble Alpes
Grenoble,
FranceActive - Recruiting
CHRU Lille
Lille,
FranceActive - Recruiting
HCL - Edouard Herriot
Lyon,
FranceActive - Recruiting
HCL - Lyon Sud
Lyon,
FranceSite Not Available
AP-HM Timone
Marseille,
FranceSite Not Available
CH Melun
Melun,
FranceActive - Recruiting
CHRU Montpellier
Montpellier,
FranceSite Not Available
CHU Nantes
Nantes,
FranceActive - Recruiting
CHU Nîmes
Nîmes,
FranceSite Not Available
AP-HP - Avicenne
Paris,
FranceSite Not Available
AP-HP Lariboisière
Paris,
FranceActive - Recruiting
AP-HP Pitié Salpetrière
Paris,
FranceActive - Recruiting
CHU Poitiers
Poitiers,
FranceActive - Recruiting
Chu Reunion
Saint Pierre, 97448
FranceActive - Recruiting
CHU Réunion
Saint-Denis, 97400
FranceActive - Recruiting
CHU Toulouse
Toulouse,
FranceActive - Recruiting
CH Monaco
Monaco,
MonacoActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.