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Not Yet RecruitingNCT06784284

PREhospital Prediction of the Risk of Intracranial Hemorrhagic Injury in the Elderly Patient with a Fall

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
1,100 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGlasgow 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

Timeline

Start date
2025-02-01
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2025-01-20
Last updated
2025-01-27

Source: ClinicalTrials.gov record NCT06784284. Inclusion in this directory is not an endorsement.