Intracerebral Hemorrhage；Circulating ExosomesNCT05035134
Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage；Circulating Exosomes, run by Tang-Du Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage；Circulating Exosomes
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All of the ICH patients receiving treatment in Tangdu Hospital during 2021-2022
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tandu Hospital, Fourth Military Medical University
Xi'an
Xun Wu, M.D, 86-15609261331, 2645302700@qq.com
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
The type and content of circulating exosomes
After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes
Measured: within 24 hours of ICH
Modified Rankin scale (mRS) scores
mRS scores was divided into seven grades (0-6). The higher the score, the more severe the symptoms
Measured: from onset to three months or six months
Secondary outcomes (2)
mortality
Measured: through study completion，an average of 1 year
hospital stay
Measured: From hospitalization to discharge，up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start12 Sep 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage；Circulating ExosomesStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, M.D, Ph.D, Study chair, Tang-Du HospitalXun Wu, M.D, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035134
- Sponsor's protocol ID
- TDSJWKICHEX
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05035134
- Acronym / sponsor ID
- TDSJWKICHEX
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 12 Sep 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All of the ICH patients receiving treatment in Tangdu Hospital during 2021-2022
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
mortality
Time frame: through study completion，an average of 1 year
hospital stay
Time frame: From hospitalization to discharge，up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Qu, M.D, Ph.D study chair
Tang-Du Hospital
Xun Wu, M.D principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage；Circulating Exosomes, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xun Wu, M.D (86-15609261331, 2645302700@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type and content of circulating exosomes (time frame: within 24 hours of ICH). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.