Intracerebral HemorrhageNCT07172542
High Risk of Death or Disability in Brain Hemorrhage: Role of Spot Sign and Secondary Markers
An observational study of Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Centre Hospitalier de Gonesse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Stroke
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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).
Who may be able to join
- 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).
Who cannot join
- Patient deceased before the initial contrast-enhanced CT.
- Major missing clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier de Gonesse
Gonesse, France
Abdullah BLAKIME, 01.34.53.24.64, coordination.rechercheclinique@ghtpdfr.fr
About this study
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
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral Hemorrhage Without Spot Sign or Secondary Morphological Marker | Not described | |
| Spot Sign Only | Not described | |
| Spot Sign With a Secondary Morphological Marker | Not described | |
| Single Secondary Morphological Marker Without Spot Sign | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Gonesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172542
- Sponsor's protocol ID
- 0125_REANIMATION_SPOT-TARGET
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk of Death or Disability in Brain Hemorrhage: Role of Spot Sign and Secondary Markers
- ClinicalTrials.gov ID
- NCT07172542
- Acronym / sponsor ID
- 0125_REANIMATION_SPOT-TARGET
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Stroke, Brain Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier de GonesseUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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).
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patient deceased before the initial contrast-enhanced CT.
- Major missing clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Centre Hospitalier de Gonesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.