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

August 31, 2021 updated by: Tang-Du Hospital
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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All of the ICH patients receiving treatment in Tangdu Hospital during 2021-2022

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours of ICH
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
from onset to three months or six months

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: through study completion，an average of 1 year
through study completion，an average of 1 year
hospital stay
Time Frame: From hospitalization to discharge，up to one month
From hospitalization to discharge，up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, M.D, Ph.D, Tang-Du Hospital
  • Principal Investigator: Xun Wu, M.D, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 12, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKICHEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracerebral Hemorrhage；Circulating Exosomes

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