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
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.
- 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