An observational study in Light Head Injury, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by University Hospital, Caen · Observational
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Among 36 studies in Craniocerebral Trauma with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Craniocerebral Trauma · France.
Among the 36 studies in Craniocerebral Trauma with a site in France, this one is the 8th largest by planned enrollment of the 21 observational ones that give a count, is the only one that started in 2018, is one of 21 observational ones, and was the 19th registered.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
Browse Craniocerebral Trauma studies →6 of the 36 studies in Craniocerebral Trauma with a site in France are open now. Recruiting first, the newest first:
University Hospital, Toulouse · Sites in France
Ages 18–60
University Hospital, Grenoble · Sites in France
Ages 1 mo–17 yrs
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
Ages 18–75
University Hospital, Strasbourg, France · Sites in France
Ages 18+
CHU de Reims · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes.
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36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 5
First in 1983; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 400 is above the median of 180 across 111 observational studies indexed under Craniocerebral Trauma.
Median enrollment 60 across the 15 interventional studies, 130 across the 21 observational. Of the 22 that completed or were terminated, 0 (0%) have results posted.
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1 of 36 have an industry lead sponsor. The 10 most frequent:
University Hospital, Caen is the lead sponsor of 513 studies on the registry; 83 are open to participants now.
University Hospital, Caen has 1 study filed under Craniocerebral Trauma — fewer than ten, so there is no comparison to draw.
2 of the studies in Craniocerebral Trauma with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06077695University Hospital, ToulouseCognitive Remediation of Working Memory Post Head Trauma | 2027-07-06 |
| NCT06642896University Hospital, GrenobleQuantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy | 2027-10-31 |
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Among the 36 studies in Craniocerebral Trauma with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Head injuries are a major public health issue, with an estimated annual incidence in Europe of 262 per 100,000 population. Light head injury (SCI), defined by a Glasgow score between 13 and 15, constitutes the majority (71% to 98%) of head injury cases. Despite a generally good prognosis, patients with TCL have a low but real risk of brain damage, whose prevalence is estimated at 5%. Cerebral computed tomography (CT) because of its high sensitivity for the detection of posttraumatic intracranial lesions (LIC), is currently considered the gold standard for the diagnosis of these lesions in patients considered at risk after clinical evaluation. The number of cTCTs performed is high with no lesion in more than 90% of cases. The S100B protein, a marker of brain tissue damage, is reported to reliably exclude the presence of brain lesions in adults as well as antiaggregants. These numerous studies show that its serum assay in combination with the clinical decision algorithms allows, thanks to a sensitivity close to 100% for brain lesions, to reduce the number of CTMc currently prescribed by approximately 30%, and therefore to decrease unnecessary exposure to radiation. Although there is no study on the subject, a gain on the duration of care in emergencies can be expected as well as a reduction on the cost of care by a dosage price three times less higher than the TDMc. Expert opinion for the use of this assay in the management of moderate-risk TCL at threshold ≤ 0.10 μg / L in 3h post-TC to ensure sensitivity of 100%, was published in 2014 in the Annales Françaises de Médecine d'Urgence.
The use of anticoagulants has continued to increase in recent years. In 2013, it is estimated that 3.12 million patients received at least one anticoagulant in France. Currently, the international and French recommendations indicate the achievement of cTCT in anticoagulated TCL because it is an independent risk factor for cerebral injury and is therefore considered to be a high risk TCL. LIC. The hypothesis of this study is that the S100B protein assay could also exclude the presence of brain lesion after TCL under anticoagulation in adults
Exclusion Criteria:
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serum S100B protein assay measurement within the 3 hours after head trauma
S100B protein serum concentration
The main objective of this study is to evaluate whether a negative serum assay of S100B protein (≤ 0.10 μg / L) within 3 hours after head trauma
Time frame: baseline (maximum 3 hours after head trauma)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2018; primary completion for Mar 2020, 24 months later.
Of 43 non-industry observational studies under Craniocerebral Trauma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's planned 24 months is below that.
Counting every sponsor, half of 43 studies reached it within 32 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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