NCT04305821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

March 10, 2020

Last Update Submit

April 11, 2023

Conditions

Mild Head InjuryAnticoagulantAntiplatelet

Keywords

Mild head injury, traumatic brain injury, traumatic intracranial hemorrhageAnticoagulant, antiplatelet, anticoagulant, antithromboticS100β proteinhealth care cost

Outcome Measures

Primary Outcomes (3)

  • Diagnostic performances are evaluated by AUC

    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 sensibility, specificity

    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 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 positive and negative predictive values between the strategy with S100β protein compared to the strategy with systematic cranial computed tomography.

    1 day

Interventions

Dosage of S100β proteinOTHER

Dosage of S100β protein

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient taking antithrombotic medication with mild head trauma and trauma occured ≤ 6 hours

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Cédric GANGLOFF, MD

    Centre Hospitalier Univesitaire de Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

March 9, 2020

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)