Clinical trial NCT06784284: PREhospital Prediction of the Risk of Intracranial Hemorrhagic Injury in the Elderly Patient with a Fall
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Hemorrhages
Head Trauma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 1100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All callers (≥ 65 years old) contacting the centre 15 for head trauma following a fall from a height

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* patient ≥ 65 years old
* call to the SAMU/centre 15 following a fall from a height (bed, chair, standing)
* proven or suspected head trauma

Exclusion Criteria:

* high fall kinetics (greater than 1 m or 5 steps, pedestrian knocked down)

Primary outcomes:
measure: prediction of the risk of intracerebral haemorrhagic injury
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: