Investigation of Protein Heterogeneity in Extracellular Vesicles Derived From Different Human Blood Circulatory Regions

NCT07439965 | Recruiting DMC

• 1 other identifier: 25K218-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Subarachnoid Aneurysm Hemorrhage; Unruptured Intracranial Aneurysm

Keywords

extracellular vesicles; blood; subarachnoid hemorrhage; intracranial aneurysm

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 7 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Central Study Contacts

Zheng Wan, Medical Doctor， MD

CONTACT

86-18743059601; wanzheng@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: July 29, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-06

Locations

CN (1)