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

Anticoagulant Clinical Trial

— ISTCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305821
• Other study ID #: 35RC19_30046_ISTCAT
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• 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

Related Conditions & MeSH terms

• Anticoagulant
• Antiplatelet
• Craniocerebral Trauma
• Mild Head Injury

Intervention

Other:
• Dosage of S100ß protein
Dosage of S100ß protein

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Roche Diagnostics

Country where clinical trial is conducted

France, 

Outcome

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