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Clinical Trials/NCT05035134
NCT05035134
Unknown
Not Applicable

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

Tang-Du Hospital1 site in 1 country300 target enrollmentSeptember 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Hemorrhage;Circulating Exosomes
Sponsor
Tang-Du Hospital
Enrollment
300
Locations
1
Primary Endpoint
The type and content of circulating exosomes
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 12, 2021
End Date
July 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tang-Du Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The type and content of circulating exosomes

Time Frame: within 24 hours of ICH

After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes

Modified Rankin scale (mRS) scores

Time Frame: 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

Secondary Outcomes

  • mortality(through study completion,an average of 1 year)
  • hospital stay(From hospitalization to discharge,up to one month)

Study Sites (1)

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