Transcranial Ultrasonography for the Management of Patients With Mild TBI (NCT03989999) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transcranial Ultrasonography for the Management of Patients With Mild TBI
France550 participantsStarted 2020-02-01
Plain-language summary
The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 SpO2 greater than 92% and a hemoglobin concentration greater than 8g/dl, or, in the absence of measured physiologic parameters or the absence of biological sampling, mention in the patient's medical record of a stable clinical examination in terms of hemodynamics and respiratory function.
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 hemostasi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome