NCT06444438

Brief Summary

Subarachnoid hemorrhage (SAH) is a common and extremely critical disease in neurosurgery. The mortality rate within 30 days of the onset of SAH is as high as 50%, and about 15% of SAH patients die without reaching the hospital. Nearly half of the survivors have severe neurological dysfunction, causing a huge burden to the families and society of the patients. Recently, the introduction of the "glymphatic-meningeal lymphatic vessels" drainage system has updated the current concept of intracranial cerebrospinal fluid circulation. After subarachnoid hemorrhage, a large number of blood components flooded into the subarachnoid space and entered the cerebrospinal fluid circulation, which directly affected the function of the lymphatic-meningeal lymphatic drainage system. Many preclinical animal studies have pointed out that the damage of the lymphatic-meningeal lymphatic drainage system is involved in the aggravation of cerebral edema, neuroinflammation and hydrocephalus after SAH, which ultimately leads to poor prognosis of patients. However, at present, the changes of the glymphatic-meningeal lymphatic drainage system after SAH have only been confirmed in animal models, and clinical evidence is lacking. With the development of imaging technology, many research teams have confirmed the functional changes of the lymphatic-meningeal lymphatic drainage system in Alzheimer's disease and Parkinson's disease by using different sequences of non-invasive MRI, such as 3D T2-FLAIR, DTI-ALPS and other sequences.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

May 31, 2024

Last Update Submit

May 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The drainage function of the glymphatic system - meningeal lymphatic vessels

    The drainage function of the lgymphatic system - meningeal lymphatic vessels was observed by magnetic resonance

    Within 7 days after admission

Study Arms (2)

Ruptured aneurysm

Patients with aneurysmal subarachnoid hemorrhage

Diagnostic Test: subarachnoid hemorrhage

Unruptured aneurysm

Patients with unruptured aneurysm

Interventions

CT presented subarachnoid hemorrhage

Ruptured aneurysm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patient had no prior brain disease and had a subarachnoid hemorrhage due to a ruptured aneurysm.

You may qualify if:

  • ①18-80 years old; ② Voluntary patients with spontaneous subarachnoid hemorrhage undergoing aneurysm interventional therapy.

You may not qualify if:

  • ①A history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., leaving associated chronic changes on CT); ②Patients with imaging data loss and severe comorbidities prior to the onset of SAH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Subarachnoid HemorrhageLymphatic Diseases

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 5, 2024

Study Start

May 1, 2024

Primary Completion

May 20, 2025

Study Completion

May 30, 2025

Last Updated

June 5, 2024

Record last verified: 2024-03

Locations