NCT07665255

Brief Summary

This is a single-center, investigator-initiated, prospective observational case-control study. Patients with intracerebral hemorrhage and healthy controls will be enrolled at Xuanwu Hospital, Capital Medical University. Peripheral venous blood samples will be collected for measurement of CIRP, Cathepsin B, and related inflammatory biomarkers. Clinical and imaging data will also be collected in the intracerebral hemorrhage group. The study aims to compare biomarker levels between patients with intracerebral hemorrhage and healthy controls and to explore the potential role of these biomarkers in neuroinflammation after intracerebral hemorrhage. No investigational treatment will be administered.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
29mo left

Started Jul 2026

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 15, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

NeuroinflammationcirpCathepsin B

Outcome Measures

Primary Outcomes (1)

  • Peripheral Blood CIRP Level

    Comparison of peripheral blood CIRP levels between the intracerebral hemorrhage group and the healthy control group.

    Within 24 hours after enrollment for the intracerebral hemorrhage group; once at baseline on the day of blood collection for healthy controls.

Study Arms (2)

Intracerebral Hemorrhage Group

Adults with intracerebral hemorrhage confirmed by head CT or MRI, admitted within 24 hours after symptom onset, and prospectively enrolled after informed consent. Peripheral venous blood samples (4-5 mL) will be collected, and clinical and imaging data will also be obtained.

Other: Blood Sample Collection

Healthy Control Group

Age-eligible healthy controls recruited prospectively from the hospital health examination center after informed consent. One peripheral venous blood sample (4-5 mL) will be collected, together with basic demographic and health-related information.

Other: Blood Sample Collection

Interventions

Peripheral venous blood sample collection for biomarker measurement only; no investigational treatment is administered.

Healthy Control GroupIntracerebral Hemorrhage Group

Eligibility Criteria

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

Adults with intracerebral hemorrhage admitted to Xuanwu Hospital, Capital Medical University, and age-eligible healthy controls recruited from the hospital health examination center. The intracerebral hemorrhage group includes patients with supratentorial, non-surgical intracerebral hemorrhage confirmed by CT or MRI and admitted within 24 hours after symptom onset. The healthy control group includes adults without stroke or other major neurological diseases.

You may qualify if:

  • Intracerebral hemorrhage group:
  • Age 18 years or older Diagnosis of intracerebral hemorrhage confirmed by head CT or MRI Supratentorial hemorrhage No surgical treatment Hematoma volume less than 30 mL Admission within 24 hours after symptom onset The participant or the legally authorized representative/next of kin is able to provide written informed consent
  • Healthy control group:
  • Age 18 years or older Recruited from the hospital health examination center No history of stroke, intracerebral hemorrhage, cerebral infarction, or other major neurological diseases No severe active infection, severe immune disease, hematologic disease, or end-stage severe heart, liver, or renal failure No acute infection, trauma, or other obvious stress state within the previous 2 weeks Able to provide written informed consent

You may not qualify if:

  • Intracerebral hemorrhage group:
  • Traumatic intracerebral hemorrhage Secondary intracerebral hemorrhage caused by brain tumor, cerebrovascular malformation, aneurysm, or hemorrhagic transformation of infarction Severe active infection, severe immune disease, or hematologic disease End-stage severe heart, liver, or renal failure Pregnant or lactating women Any other condition judged unsuitable by the investigator
  • Healthy control group:
  • History of stroke, intracranial hemorrhage, brain tumor, or other major neurological diseases Severe active infection, severe immune disease, or hematologic disease End-stage severe heart, liver, or renal failure Pregnant or lactating women Any other condition judged unsuitable by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples (4-5 mL per participant), including residual clinical blood samples when available, will be retained. Samples will be coded, centrifuged, aliquoted, and stored at low temperature for measurement of CIRP, Cathepsin B, and related inflammatory biomarkers.

MeSH Terms

Conditions

Cerebral HemorrhageNeuroinflammatory Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guohua Wang, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to participant privacy and confidentiality considerations. This is a single-center study involving sensitive clinical and biospecimen-derived data, and no formal external data-sharing plan has been established. Results will be reported in aggregate form only.