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Not yet recruiting NCT07172542

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

— Observational Intracerebral Hemorrhage Cerebral Hemorrhage Stroke Brain Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracerebral Hemorrhage, Cerebral Hemorrhage, Stroke, Brain Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Hospitalier de Gonesse — Gonesse

Identifiers

NCT: NCT07172542 · 0125_REANIMATION_SPOT-TARGET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗