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Completed

NCT Number: NCT06784284

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: PRELHIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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