High Risk of Death or Disability in Brain Hemorrhage: Role of Spot Sign and Secondary Markers

NCT07172542 | Not Yet Recruiting

• 1 other identifier: 0125_REANIMATION_SPOT-TARGET
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at patients with brain hemorrhage to see if a special sign on brain scans, called the "Spot Sign," combined with other scan features, can predict a higher risk of death or disability. By comparing patient outcomes with existing prediction scores, the study aims to understand whether these scan markers provide extra value in identifying patients at higher risk.

Conditions

Intracerebral Hemorrhage; Cerebral Hemorrhage; Stroke; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Hematoma Expansion within 48 Hours: Increase of more than 6 mL or over 30% between the initial CT and the follow-up CT (PREDICT study criterion) and/or Occurrence of Death Within the First Month

  48 hours

Study Arms (4)

Intracerebral Hemorrhage Without Spot Sign or Secondary Morphological Marker

Spot Sign Only

Spot Sign With a Secondary Morphological Marker

Single Secondary Morphological Marker Without Spot Sign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Source Population: Patients hospitalized for hemorrhagic stroke (spontaneous ICH) in the neurology department, with an available initial contrast-enhanced CT scan. Target Population: Patients with non-traumatic spontaneous intracerebral hemorrhage (ICH).

You may qualify if:

• Spontaneous intracerebral hemorrhage confirmed by contrast-enhanced CT scan.
• Follow-up CT scan performed within 24 to 48 hours.
• Absence of initial contrast-enhanced CT or follow-up CT.
• Hematoma due to trauma, epidural hematoma (EDH), subdural hematoma (SDH), or subarachnoid hemorrhage (SAH).

You may not qualify if:

• Patient deceased before the initial contrast-enhanced CT.
• Major missing clinical data.

Sponsors & Collaborators

• Centre Hospitalier de Gonesse: lead

Study Sites (1)

Centre Hospitalier de Gonesse

Gonesse, France, France

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

FR (1)