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

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Head Trauma
Intracranial Hemorrhages

Treatments

Other: Glasgow Outcome Scale -Extended (GOSE)

Study type

Observational

Funder types

Other

Identifiers

NCT06784284
RC31/24/0518
ID RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

1,100 participants in 1 patient group

head trauma
Description:
patient ≥ 65 years of age, calling to SAMU/centre 15 following a fall from a height (bed, chair, standing)
Treatment:
Other: Glasgow Outcome Scale -Extended (GOSE)

Trial contacts and locations

0

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Central trial contact

Xavier DUBUCS, MD

Data sourced from clinicaltrials.gov

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