High Risk of Death or Disability in Brain Hemorrhage: Rol... | NCT07172542

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

NCT07172542

Sponsor

Centre Hospitalier de Gonesse

Status

Not yet recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Intracerebral Hemorrhage
Cerebral Hemorrhage
Stroke
Brain Injuries

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2025Estimated

Primary Completion Date

May 15, 2026Estimated

Completion Date

May 15, 2026Estimated

First Submitted Date

Sep 8, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 15, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Gonesse		Gonesse	France		France

Condition Browse Module

MeSH Terms

ID	Term
D002543	Cerebral Hemorrhage
D020521	Stroke
D001930	Brain Injuries

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided