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Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics

Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04305821
Acronym
ISTCAT
Enrollment
260
Registered
2020-03-12
Start date
2020-03-09
Completion date
2021-09-20
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant, Antiplatelet, Mild Head Injury

Keywords

Mild head injury, traumatic brain injury, traumatic intracranial hemorrhage, Anticoagulant, antiplatelet, anticoagulant, antithrombotic, S100β protein, health care cost

Brief summary

Head trauma is a common injury in emergency department. Investigation to search for complication is guided by the clinical examination and the case history, such as taking anti-thrombotics. Cranial computed tomography (CCT) is the gold standard to investigate, and is mandatory in case of antithrombotic drugs. Recently, some biomarkers have proven their utility to rule-out mild head trauma without CCT in the general population. Among these biomarkers, S100β protein has been added in guidelines for mild head trauma. Some studies have found similar data in population taking anticoagulant or antiplatelet drugs. The investigators aim to prove medical utility of S100β protein in population under antithrombotics, by the reduction of CCT use. Then, The investigators hypothesize that the add of S100β protein reduces cost of health care in the management of head injury in that population.

Interventions

OTHERDosage of S100β protein

Dosage of S100β protein

Sponsors

Roche Diagnostics GmbH
CollaboratorINDUSTRY
Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patient ≥ 18 years old * Taking antithrombotic medication (antiplatelet drugs, K vitamin antagonist, direct oral anticoagulants, heparins) * Mild head trauma with Glasgow coma scale ≥ 13 * Trauma occured ≤ 6 hours * Agreeing the participation in the study

Exclusion criteria

* Head injury occured \> 6 hours * Patient \< 18 years old or under juridic protection * pregnant women * polytrauma * Glasgow coma scale ≤ 12 * ancient or actual cerebral ou cutaneous neoplasia

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performances are evaluated by AUC1 dayDiagnostic performances of S100β protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography.
Diagnostic performances are evaluated by sensibility, specificity1 dayDiagnostic performances of S100β protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography.
Diagnostic performances of S100β protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography.1 dayDiagnostic performances are evaluated by positive and negative predictive values between the strategy with S100β protein compared to the strategy with systematic cranial computed tomography.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026