Mild Head InjuryISTCATNCT04305821
Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics
An observational study of Mild Head Injury and Anticoagulant, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Head Injury, Anticoagulant, Antiplatelet
- What is being tested?
- Dosage of S100β protein
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 20 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient taking antithrombotic medication with mild head trauma and trauma occured ≤ 6 hours
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques
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.
- Conditions
- Mild Head Injury, Anticoagulant, Antiplatelet
- Being tested
- Dosage of S100β protein
- Keywords
- Mild head injury, traumatic brain injury, traumatic intracranial hemorrhage, Anticoagulant, antiplatelet, anticoagulant, antithrombotic, S100β protein, health care cost
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hemorrhage, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of S100β proteinOther
Dosage of S100β protein
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start9 Mar 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Head InjuryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Cédric GANGLOFF, MD, Principal investigator, Centre Hospitalier Univesitaire de Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305821
- Sponsor's protocol ID
- 35RC19_30046_ISTCAT
- Acronym
- ISTCAT
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quilcaille X, Reuter PG, Duval M, Bajeux E, Peschanski N. Usefulness of S100beta protein in patients on antithrombotic drugs with mild traumatic brain injury: a prospective cohort study in an emergency department. Int J Emerg Med. 2025 Dec 24;19(1):29. doi: 10.1186/s12245-025-01085-x.
PubMed 41444519
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques
- ClinicalTrials.gov ID
- NCT04305821
- Acronym / sponsor ID
- ISTCAT / 35RC19_30046_ISTCAT
- Conditions
- Mild Head Injury, Anticoagulant, Antiplatelet
- Keywords
- Mild head injury, traumatic brain injury, traumatic intracranial hemorrhage, Anticoagulant, antiplatelet, anticoagulant, antithrombotic, S100β protein, health care cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient taking antithrombotic medication with mild head trauma and trauma occured ≤ 6 hours
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Head injury occured > 6 hours
- Patient < 18 years old or under juridic protection
- pregnant women
- polytrauma
- Glasgow coma scale ≤ 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosage of S100β proteinDosage of S100β protein | Other | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 41444519Quilcaille X, Reuter PG, Duval M, Bajeux E, Peschanski N. Usefulness of S100beta protein in patients on antithrombotic drugs with mild traumatic brain injury: a prospective cohort study in an emergency department. Int J Emerg Med. 2025 Dec 24;19(1):29. doi: 10.1186/s12245-025-01085-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric GANGLOFF, MD principal investigator
Centre Hospitalier Univesitaire de Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Head Injury and Anticoagulant, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances are evaluated by AUC (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.