Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT01291706
Eligibility Criteria:
Criteria for inclusion:
* 15 years of age or more
* primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.
* with or without multiple injury.
* with no hemodynamic or respiratory distress: SAP \>90mmHg, SPO2 \>92%,hemoglobin \> 8 g/dl.
* with mild brain lesions on CTscan according to the traumatic coma data bank classification (TCDB) II: diffuse injury with cisterns present and no midline shift, mixed density lesions \<25 ml.
* Transcranial Doppler within 8 hours after the trauma.
* patient affiliated to the social security system or equivalent
Criteria for exclusion:
* Severe TBI (GCS\<9)
* Penetrating TBI
* patient with no brain CT scan
* patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)
* Hemodynamic or respiratory distress
* Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)
* previous intracranial surgery
* Patient with sedation and mechanical ventilation
* transcranial Doppler unable
* patient deprived of freedom by judicial or administrative decision
* Follow up at 7 days impossible
* Refusal consent to use data for statistics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01291706
Study Brief:
Protocol Section:
NCT01291706