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NCT Number: NCT07172542

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

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

Inclusion criteria

  • Spontaneous intracerebral hemorrhage confirmed by contrast-enhanced CT scan.
  • Follow-up CT scan performed within 24 to 48 hours.

Non-inclusion Criteria :

  • Absence of initial contrast-enhanced CT or follow-up CT.
  • Hematoma due to trauma, epidural hematoma (EDH), subdural hematoma (SDH), or subarachnoid hemorrhage (SAH).

Exclusion criteria

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

Treatment and study plan

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

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Gonesse

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

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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