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Clinical Trials/NCT04305821
NCT04305821
Completed
Not Applicable

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

Rennes University Hospital1 site in 1 country260 target enrollmentMarch 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Head Injury
Sponsor
Rennes University Hospital
Enrollment
260
Locations
1
Primary Endpoint
Diagnostic performances are evaluated by AUC
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2020
End Date
September 20, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic performances are evaluated by AUC

Time Frame: 1 day

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.

Diagnostic performances are evaluated by sensibility, specificity

Time Frame: 1 day

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.

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.

Time Frame: 1 day

Diagnostic performances are evaluated by positive and negative predictive values between the strategy with S100β protein compared to the strategy with systematic cranial computed tomography.

Study Sites (1)

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