NCT06535438

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

ICH

Outcome Measures

Primary Outcomes (1)

  • 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

    90 days

Study Arms (2)

The prognosis of cerebral hemorrhage is good at 90 days

The prognosis of cerebral hemorrhage is poor at 90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cerebral hemorrhage who met the criteria and were admitted continuously within the time period

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Huashan Hospital, Fudan University

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

August 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07