Skip to main content
OpenTrials
Completed

NCT Number: NCT04305821

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Head Injury Anticoagulant Antiplatelet Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dosage of S100β protein

Other

Dosage of S100β protein

Primary outcomes

  1. 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.

  2. 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.

  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.

    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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

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

Acronym: ISTCAT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.