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

NCT ID: NCT04305821

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-09

Study Completion Date

2021-09-20

Brief Summary

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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

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Conditions

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Mild Head Injury Anticoagulant Antiplatelet

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dosage of S100β protein

Dosage of S100β protein

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cédric GANGLOFF, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Univesitaire de Rennes

Locations

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Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC19_30046_ISTCAT

Identifier Type: -

Identifier Source: org_study_id

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