Intracranial HemorrhagesPRELHICNCT06784284
PREhospital Prediction of the Risk of Intracranial Hemorrhagic Injury in the Elderly Patient With a Fall
An observational study of Intracranial Hemorrhages and Head Trauma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intracranial Hemorrhages, Head Trauma
- What is being tested?
- Glasgow Outcome Scale -Extended (GOSE)
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to 10 Jun 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All callers (≥ 65 years old) contacting the centre 15 for head trauma following a fall from a height
Who may be able to join
- patient ≥ 65 years old
- call to the SAMU/centre 15 following a fall from a height (bed, chair, standing)
- proven or suspected head trauma
Who cannot join
- high fall kinetics (greater than 1 m or 5 steps, pedestrian knocked down)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Rule for Predicting the Risk of Intracranial Hemorrhagic Injury in Elderly Patients Contacting SAMU Centre-15 for Head Trauma Following a Fall From Their Height
Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software.
A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score < 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.
Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants.
Read the detailed description
Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. All callers (≥ 65 years of age) contacting center 15 for head trauma following a fall from a height are eligible. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software. He will complete the questionnaire at a later stage, once the patient has been taken into care.
A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score < 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.
Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants. The medical records of these patients will be consulted by the clinical research team to collect the information required for the study.
- Conditions
- Intracranial Hemorrhages, Head Trauma
- Being tested
- Glasgow Outcome Scale -Extended (GOSE)
- Medical subject headings
- Intracranial Hemorrhages, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glasgow Outcome Scale -Extended (GOSE)Other
Questionnaire to cotate the neurological deterioration following mild head trauma. Score from 1 to 8, the higher the number the better the outcome
| Study group | Role | What they receive |
|---|---|---|
| head trauma | patient ≥ 65 years of age, calling to SAMU/centre 15 following a fall from a height (bed, chair, standing) Receives: Other: Glasgow Outcome Scale -Extended (GOSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of the risk of intracerebral haemorrhagic injury
identify a risk of intracerebral haemorrhage with a composite criterium : identification of a traumatic haemorrhagic lesion on brain imaging performed in the emergency department or a GOS-E score (Extended Glasgow Score) of 1 to 6 at the time of the call at D7 in patients who were not transferred to an emergency department or who had not had a brain scan
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start10 Mar 2025
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784284
- Sponsor's protocol ID
- RC31/24/0518
- Other IDs
- ID RCB
- Acronym
- PRELHIC
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Rule for Predicting the Risk of Intracranial Hemorrhagic Injury in Elderly Patients Contacting SAMU Centre-15 for Head Trauma Following a Fall From Their Height
- ClinicalTrials.gov ID
- NCT06784284
- Acronym / sponsor ID
- PRELHIC / RC31/24/0518
- Conditions
- Intracranial Hemorrhages, Head Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 20 Jan 2025 (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.
Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software.
A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score < 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.
Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants.
Detailed description
Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. All callers (≥ 65 years of age) contacting center 15 for head trauma following a fall from a height are eligible. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software. He will complete the questionnaire at a later stage, once the patient has been taken into care.
A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score < 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.
Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants. The medical records of these patients will be consulted by the clinical research team to collect the information required for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head trauma | – | Other: Glasgow Outcome Scale -Extended (GOSE)patient ≥ 65 years of age, calling to SAMU/centre 15 following a fall from a height (bed, chair, standing) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All callers (≥ 65 years old) contacting the centre 15 for head trauma following a fall from a height
Key inclusion criteria (3 listed)
- patient ≥ 65 years old
- call to the SAMU/centre 15 following a fall from a height (bed, chair, standing)
- proven or suspected head trauma
Key exclusion criteria (1 listed)
- high fall kinetics (greater than 1 m or 5 steps, pedestrian knocked down)
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 |
|---|---|---|
| Glasgow Outcome Scale -Extended (GOSE)Questionnaire to cotate the neurological deterioration following mild head trauma. Score from 1 to 8, the higher the number the better the outcome | Other | head trauma |
Primary outcome
prediction of the risk of intracerebral haemorrhagic injury
Time frame: day 7
identify a risk of intracerebral haemorrhage with a composite criterium : identification of a traumatic haemorrhagic lesion on brain imaging performed in the emergency department or a GOS-E score (Extended Glasgow Score) of 1 to 6 at the time of the call at D7 in patients who were not transferred to an emergency department or who had not had a brain scan
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 29 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracranial Hemorrhages and Head Trauma, run by University Hospital, Toulouse 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 3 inclusion and 1 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 29 Jun 2026. 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?
prediction of the risk of intracerebral haemorrhagic injury (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.