Anticoagulant Clinical Trial
— ISTCATOfficial title:
Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques
Verified date | April 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | September 20, 2021 |
Est. primary completion date | September 20, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Roche Diagnostics |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performances are evaluated by AUC | Diagnostic performances of S100ß protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography. | 1 day | |
Primary | Diagnostic performances are evaluated by sensibility, specificity | Diagnostic performances of S100ß protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography. | 1 day | |
Primary | Diagnostic performances of S100ß 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 positive and negative predictive values between the strategy with S100ß protein compared to the strategy with systematic cranial computed tomography. | 1 day |
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