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

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04305821
• Collaborator: Roche Diagnostics (Industry)
• Enrollment: 170
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 14.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Head Injury; Anticoagulant; Antiplatelet	Other: Dosage of S100β protein

Study Design

• Study Type: Observational
• Anticipated Enrollment: 170 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques
• Actual Study Start Date: Mar 6, 2020
• Anticipated Primary Completion Date: Mar 6, 2021
• Anticipated Study Completion Date: Mar 7, 2021

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Rennes	Rennes		France	35000

Sponsors and Collaborators

• Rennes University Hospital
• Roche Diagnostics

Investigators

• Principal Investigator: Cédric GANGLOFF, MD, Centre Hospitalier Univesitaire de Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT04305821
• Other Study ID Numbers: 35RC19_30046_ISTCAT
• First Posted: Mar 12, 2020
• Last Update Posted: May 7, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rennes University Hospital: Mild head injury, traumatic brain injury, traumatic intracranial hemorrhage; Anticoagulant, antiplatelet, anticoagulant, antithrombotic; S100β protein; health care cost
• Additional relevant MeSH terms: Craniocerebral Trauma

Study Results

No Results Posted as of May 7, 2020