Intracerebral HemorrhageNCT06535438
The Role of Noncontrast Computed Tomography Markers in Predicting the Clinical Outcome of Cerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by Jin Hu.
Trial summary
The goal of this observational study is to To investigate the ability of Noncontrast Computed Tomography to predict clinical prognosis in Intracerebral Hemorrhage. The main question it aims to answer is:How to judge the prognosis of patients with cerebral hemorrhage by CT image reading at admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cerebral hemorrhage who met the criteria and were admitted continuously within the time period
Who may be able to join
- Age≥18 years
- had completed a CT examination within 24 h of disease onset;
- had a hemorrhage that was located in the brain parenchyma, including the basal ganglia, thalamus,brain lobes, brainstem, and cerebellum.
Who cannot join
- had secondary ICH caused by brain trauma,cerebrovascular malformations, aneurysms, and tumors;
- had ischemic cerebral infarction hemorrhagic transformation;
- had undergone surgical treatment (e.g.hematoma removal or puncture drainage) before the CT examination;
- had images of poor quality that could notbe accurately evaluated;
- had a hematoma withborders that could not be delineated, thus precluding delineation of the region of interest (ROI).
About this study
The goal of this observational study is to To investigate the ability of Noncontrast Computed Tomography to predict clinical prognosis in Intracerebral Hemorrhage.
The main question it aims to answer is:How to judge the prognosis of patients with cerebral hemorrhage by CT image reading at admission.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- ICH
- Medical subject headings
- Cerebral Hemorrhage
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 |
|---|---|---|
| The prognosis of cerebral hemorrhage is good at 90 days | Not described | |
| The prognosis of cerebral hemorrhage is poor at 90 days | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognosis of cerebral hemorrhage at 90 days
The Modified Rankin Scale was used to evaluate the prognosis of the patients, and MRS Score >2 indicated poor prognosis
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Hu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535438
- Sponsor's protocol ID
- FDHS2024
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei L, Wu B, Guo T, Ru D, Gao C, Wu J, Wu A, Yue H, Hu J, Wei L, Geng Z, Wang K. Development and validation of a machine learning-based model for 90-day prognosis outcome in spontaneous intracerebral hemorrhage patients based on non-contrast computed tomography: a multicenter retrospective observational study. EClinicalMedicine. 2025 Sep 12;88:103507. doi: 10.1016/j.eclinm.2025.103507. eCollection 2025 Oct.
PubMed 41181845
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Noncontrast Computed Tomography Markers in Predicting the Clinical Outcome of Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06535438
- Acronym / sponsor ID
- FDHS2024
- Conditions
- Intracerebral Hemorrhage
- Keywords
- ICH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jin HuUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Aug 2024 (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.
The goal of this observational study is to To investigate the ability of Noncontrast Computed Tomography to predict clinical prognosis in Intracerebral Hemorrhage.
The main question it aims to answer is:How to judge the prognosis of patients with cerebral hemorrhage by CT image reading at admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The prognosis of cerebral hemorrhage is good at 90 days | – | – |
| The prognosis of cerebral hemorrhage is poor at 90 days | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebral hemorrhage who met the criteria and were admitted continuously within the time period
Key inclusion criteria (3 listed)
- Age≥18 years
- had completed a CT examination within 24 h of disease onset;
- had a hemorrhage that was located in the brain parenchyma, including the basal ganglia, thalamus,brain lobes, brainstem, and cerebellum.
Key exclusion criteria (5 listed)
- had secondary ICH caused by brain trauma,cerebrovascular malformations, aneurysms, and tumors;
- had ischemic cerebral infarction hemorrhagic transformation;
- had undergone surgical treatment (e.g.hematoma removal or puncture drainage) before the CT examination;
- had images of poor quality that could notbe accurately evaluated;
- had a hematoma withborders that could not be delineated, thus precluding delineation of the region of interest (ROI).
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
The prognosis of cerebral hemorrhage at 90 days
Time frame: 90 days
The Modified Rankin Scale was used to evaluate the prognosis of the patients, and MRS Score >2 indicated poor prognosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 41181845Wei L, Wu B, Guo T, Ru D, Gao C, Wu J, Wu A, Yue H, Hu J, Wei L, Geng Z, Wang K. Development and validation of a machine learning-based model for 90-day prognosis outcome in spontaneous intracerebral hemorrhage patients based on non-contrast computed tomography: a multicenter retrospective observational study. EClinicalMedicine. 2025 Sep 12;88:103507. doi: 10.1016/j.eclinm.2025.103507. eCollection 2025 Oct.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Jin Hu.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognosis of cerebral hemorrhage at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535438, which also lists 1 linked publication.
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 2 Aug 2024.