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

NCT06784284 | Not Yet Recruiting

• 2 other identifiers: RC31/24/0518ID RCB
• Study Type: observational
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Hemorrhages; Head Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

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

head trauma

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Intracranial Hemorrhages; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Xavier DUBUCS, MD

CONTACT

5 61 77 59 61; dubucs.x@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01