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

Completed

• Conditions: Mild Head Injury; Antiplatelet; Anticoagulant

• Registration Number: NCT04305821
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-09
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-12
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performances are evaluated by AUC	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	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.	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Rennes; 🇫🇷 Rennes, France