Subarachnoid Aneurysm HemorrhageDBCR-EV-pNCT07439965
Investigation of Protein Heterogeneity in Extracellular Vesicles Derived From Different Human Blood Circulatory Regions
An observational study of Subarachnoid Aneurysm Hemorrhage and Unruptured Intracranial Aneurysm, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the protein heterogeneity in extracellular vesicles (EVs) derived from different human blood circulatory regions of patients with ruptured or unruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Subarachnoid Aneurysm Hemorrhage, Unruptured Intracranial Aneurysm
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2025to Jun 2026
- How long will I take part?
- 120 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This is an exploratory study, and to date, there have been no similar reports in the literature. The primary outcome will be differences in proteomic profiles, which may yield hundreds of differential results. Based on the planned budget and clinical experience, we preliminarily aim to enroll 60 patients with aneurysmal subarachnoid hemorrhage and 60 patients with unruptured intracranial aneurysms. Proteomic analysis of extracellular vesicles from the first 30 patients will be used to identify intergroup differential markers of interest, which will then guide further adjustments to the sample size in the subsequent phase of the study.
Who may be able to join
- 1. Aged between 18 and 60 years, regardless of gender; 2. Diagnosed with intracranial aneurysm confirmed by MRA, CTA, or DSA; 3. Patients with aneurysmal subarachnoid hemorrhage must have CT imaging evidence of hemorrhage, and blood collection must occur within 3 days of symptom onset; 4. Scheduled to undergo neurointerventional surgery for intracranial aneurysm under general anesthesia, with the procedure starting between 8:00 AM and 12:00 PM; 5. Willing to comply with the study protocol and data collection procedures; 6. Able to understand and sign the informed consent form.
Who cannot join
- 1. Patients with a pre-onset (in hemorrhagic cases) or preoperative (in non-hemorrhagic cases) Modified Rankin Scale (MRS) score ≥ 2; 2. Presence of other neurological disorders such as Parkinson's disease, Alzheimer's disease, cerebral infarction, brain tumors, epilepsy, etc.; 3. Presence of other systemic diseases such as diabetes, coronary artery disease, cancer, infections, hematological diseases, or severe metabolic disorders that may significantly affect the evaluation of blood EVs; 4. History of severe hepatic or renal dysfunction (ALT > 3 times the upper limit of normal; creatinine > 225 μmol/L); 5. Patients who cannot tolerate anesthesia, anticoagulant therapy, or who have coagulation disorders; 6. History of severe allergic reactions to contrast agents; 7. Pregnant women; 8. Patients participating in other clinical trials who have not yet completed follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Zheng Wan, M.D., 86-18743059601, wanzheng@jlu.edu.cn
About this study
The goal of this observational study is to learn about the protein heterogeneity in extracellular vesicles (EVs) derived from different human blood circulatory regions of patients with ruptured or unruptured intracranial aneurysms. The main objectives are:
Reveal the proteomic heterogeneity of EVs in different blood circulatory regions of the human body。 Reveal the proteomic differences of EVs in cerebral feeding arteries and draining veins between patients with aneurysmal subarachnoid hemorrhage and those without hemorrhage.
Explore EV-derived protein biomarkers that reflect the diagnosis and prognosis of subarachnoid hemorrhage
Read the detailed description
Extracellular vesicles (EVs) are small lipid bilayer-enclosed vesicles that are widely secreted by almost all types of cells into the extracellular microenvironment. They carry biomolecules such as proteins, lipids, mRNA, and miRNA, and play important roles in intercellular communication and disease regulation. Due to their stability and specificity, EVs have become a research hotspot for the diagnosis and prognosis of various diseases.
Currently, existing studies on blood-derived EVs mostly rely on samples collected from peripheral veins, such as the brachial vein. However, there is a lack of research investigating the heterogeneity of EV contents across different vascular regions of the human body, such as arteries and deep veins in the head and neck.
Neurointerventional surgery is a minimally invasive, imaging-guided medical technique that utilizes microcatheters, micro guidewires, and other instruments to access target vessels through the vascular system for the diagnosis and treatment of cerebrovascular diseases. This technique allows for the collection of blood samples from arteries or veins in the head and neck during the surgical procedure.
This project proposes to collect blood samples from the femoral vein, internal jugular vein, and internal carotid artery of patients with ruptured or unruptured intracranial aneurysms undergoing neurointerventional procedures under general anesthesia. EVs will be extracted for proteomic differential analysis, aiming to characterize the heterogeneity of EVs across different vascular regions in the human body and to explore potential diagnostic and prognostic protein biomarkers for aneurysmal subarachnoid hemorrhage.
- Keywords
- extracellular vesicles, blood, subarachnoid hemorrhage, intracranial aneurysm
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ruptured intracranial aneurysms | Patients with intracranial aneurysms who have suffered subarachnoid hemorrhage (CT-confirmed diagnosis of bleeding) need to be treated with endovascular surgeries. The blood sample collection during the surgery for hemorrhagic cases must occur within 3 days of symptom onset. | |
| Patients with unruptured intracranial aneurysms | Patients with intracranial aneurysms without subarachnoid hemorrhage need to be treated with endovascular surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics of extracellular vesicles (EVs) derived from different blood circulatory regions
During neurointerventional procedures under general anesthesia, 5 mL of blood will be collected from the patient's femoral vein, internal jugular vein, and internal carotid artery. After centrifugation to obtain plasma, extracellular vesicles will be extracted for proteomic detection and analysis.
Measured: From enrollment to the end of treatment at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Jul 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Aneurysm HemorrhageStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439965
- Sponsor's protocol ID
- 25K218-001
- Acronym
- DBCR-EV-p
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Protein Heterogeneity in Extracellular Vesicles Derived From Different Human Blood Circulatory Regions
- ClinicalTrials.gov ID
- NCT07439965
- Acronym / sponsor ID
- DBCR-EV-p / 25K218-001
- Keywords
- extracellular vesicles, blood, subarachnoid hemorrhage, intracranial aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (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 goal of this observational study is to learn about the protein heterogeneity in extracellular vesicles (EVs) derived from different human blood circulatory regions of patients with ruptured or unruptured intracranial aneurysms. The main objectives are:
Reveal the proteomic heterogeneity of EVs in different blood circulatory regions of the human body。 Reveal the proteomic differences of EVs in cerebral feeding arteries and draining veins between patients with aneurysmal subarachnoid hemorrhage and those without hemorrhage.
Explore EV-derived protein biomarkers that reflect the diagnosis and prognosis of subarachnoid hemorrhage
Detailed description
Extracellular vesicles (EVs) are small lipid bilayer-enclosed vesicles that are widely secreted by almost all types of cells into the extracellular microenvironment. They carry biomolecules such as proteins, lipids, mRNA, and miRNA, and play important roles in intercellular communication and disease regulation. Due to their stability and specificity, EVs have become a research hotspot for the diagnosis and prognosis of various diseases.
Currently, existing studies on blood-derived EVs mostly rely on samples collected from peripheral veins, such as the brachial vein. However, there is a lack of research investigating the heterogeneity of EV contents across different vascular regions of the human body, such as arteries and deep veins in the head and neck.
Neurointerventional surgery is a minimally invasive, imaging-guided medical technique that utilizes microcatheters, micro guidewires, and other instruments to access target vessels through the vascular system for the diagnosis and treatment of cerebrovascular diseases. This technique allows for the collection of blood samples from arteries or veins in the head and neck during the surgical procedure.
This project proposes to collect blood samples from the femoral vein, internal jugular vein, and internal carotid artery of patients with ruptured or unruptured intracranial aneurysms undergoing neurointerventional procedures under general anesthesia. EVs will be extracted for proteomic differential analysis, aiming to characterize the heterogeneity of EVs across different vascular regions in the human body and to explore potential diagnostic and prognostic protein biomarkers for aneurysmal subarachnoid hemorrhage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 120 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ruptured intracranial aneurysms | – | –Patients with intracranial aneurysms who have suffered subarachnoid hemorrhage (CT-confirmed diagnosis of bleeding) need to be treated with endovascular surgeries. The blood sample collection during the surgery for hemorrhagic cases must occur within 3 days of symptom onset. |
| Patients with unruptured intracranial aneurysms | – | –Patients with intracranial aneurysms without subarachnoid hemorrhage need to be treated with endovascular surgeries. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is an exploratory study, and to date, there have been no similar reports in the literature. The primary outcome will be differences in proteomic profiles, which may yield hundreds of differential results. Based on the planned budget and clinical experience, we preliminarily aim to enroll 60 patients with aneurysmal subarachnoid hemorrhage and 60 patients with unruptured intracranial aneurysms. Proteomic analysis of extracellular vesicles from the first 30 patients will be used to identify intergroup differential markers of interest, which will then guide further adjustments to the sample size in the subsequent phase of the study.
Key inclusion criteria (1 listed)
- 1. Aged between 18 and 60 years, regardless of gender; 2. Diagnosed with intracranial aneurysm confirmed by MRA, CTA, or DSA; 3. Patients with aneurysmal subarachnoid hemorrhage must have CT imaging evidence of hemorrhage, and blood collection must occur within 3 days of symptom onset; 4. Scheduled to undergo neurointerventional surgery for intracranial aneurysm under general anesthesia, with the procedure starting between 8:00 AM and 12:00 PM; 5. Willing to comply with the study protocol and data collection procedures; 6. Able to understand and sign the informed consent form.
Key exclusion criteria (1 listed)
- 1. Patients with a pre-onset (in hemorrhagic cases) or preoperative (in non-hemorrhagic cases) Modified Rankin Scale (MRS) score ≥ 2; 2. Presence of other neurological disorders such as Parkinson's disease, Alzheimer's disease, cerebral infarction, brain tumors, epilepsy, etc.; 3. Presence of other systemic diseases such as diabetes, coronary artery disease, cancer, infections, hematological diseases, or severe metabolic disorders that may significantly affect the evaluation of blood EVs; 4. History of severe hepatic or renal dysfunction (ALT > 3 times the upper limit of normal; creatinine > 225 μmol/L); 5. Patients who cannot tolerate anesthesia, anticoagulant therapy, or who have coagulation disorders; 6. History of severe allergic reactions to contrast agents; 7. Pregnant women; 8. Patients participating in other clinical trials who have not yet completed follow-up.
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
Proteomics of extracellular vesicles (EVs) derived from different blood circulatory regions
Time frame: From enrollment to the end of treatment at 7 days
During neurointerventional procedures under general anesthesia, 5 mL of blood will be collected from the patient's femoral vein, internal jugular vein, and internal carotid artery. After centrifugation to obtain plasma, extracellular vesicles will be extracted for proteomic detection and analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Subarachnoid Aneurysm Hemorrhage and Unruptured Intracranial Aneurysm, run by The First Hospital of Jilin University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wan, Medical Doctor， MD (86-18743059601, wanzheng@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics of extracellular vesicles (EVs) derived from different blood circulatory regions (time frame: From enrollment to the end of treatment at 7 days). 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 27 Feb 2026.