Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage

• Conditions: Intracerebral Hemorrhage；Circulating Exosomes

• Registration Number: NCT05035134
• Lead Sponsor: Tang-Du Hospital

Brief Summary

The purpose of this study is to observe the relationship between the changes of circulating exosomes and the development and outcome of the disease in patients with intracerebral hemorrhage, and to search for early serum markers and potential intervention targets for disease monitoring in patients with intracerebral hemorrhage

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-26
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-31
• Last Update Submitted: 2021-08-31
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-09-12
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. No systematic treatment was given before admission;
2. The patients were diagnosed with cerebral hemorrhage, and had imaging evidence;
3. The age was more than 18 years old;
4. The patient or family member agrees to sign the informed consent.

Exclusion Criteria

1. Hematoma is caused by secondary factors (intracranial tumor, arteriovenous malformation or aneurysm);
2. Bleeding into the ventricle;
3. Multiple cerebral hemorrhage;
4. The patient did not receive treatment in our hospital;
5. Severe disability, dementia, or organ dysfunction before onset
6. Coagulopathy or long-term use of anticoagulants
7. Hematoma affects brain stem
8. Subjects refused to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS) scores	from onset to three months or six months	mRS scores was divided into seven grades (0-6). The higher the score, the more severe the symptoms
The type and content of circulating exosomes	within 24 hours of ICH	After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes

Secondary Outcome Measures

Name	Time	Method
mortality	through study completion，an average of 1 year
hospital stay	From hospitalization to discharge，up to one month

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, China