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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06444438
Other study ID # 2024-0224
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 30, 2025

Study information

Verified date March 2024
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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 in 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 30, 2025
Est. primary completion date May 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - ?18-80 years old; ? Voluntary patients with spontaneous subarachnoid hemorrhage undergoing aneurysm interventional therapy. Exclusion Criteria: - ?A history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., leaving associated chronic changes on CT); ?Patients with imaging data loss and severe comorbidities prior to the onset of SAH

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
subarachnoid hemorrhage
CT presented subarachnoid hemorrhage

Locations

Country Name City State
China the Second Affiliated Hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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