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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Hemorrhages; Head Trauma
• Intervention / Treatment: Other: Glasgow Outcome Scale -Extended (GOSE)

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 Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Xavier DUBUCS, MD; Phone Number: +33 5 61 77 59 61; Email: dubucs.x@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
head trauma; patient ≥ 65 years of age, calling to SAMU/centre 15 following a fall from a height (bed, chair, standing)	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 7

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Trauma, Nervous System; Hemorrhage; Intracranial Hemorrhages; Craniocerebral Trauma
• Other Study ID Numbers: RC31/24/0518; ID RCB (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No