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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier de Gonesse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patient deceased before the initial contrast-enhanced CT.

Major missing clinical data.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 4 trial groups
Group A: Intracerebral Hemorrhage Without Spot Sign or Secondary Morphological Marker
Group B: Spot Sign Only
Group C: Spot Sign With a Secondary Morphological Marker
Group D: Single Secondary Morphological Marker Without Spot Sign

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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