Subarachnoid HemorrhageNCT06444438
Radiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Lymphatic System Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Lymphatic System Disorder, Meningeal Lymphatic Vessels
- What is being tested?
- subarachnoid hemorrhage
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient had no prior brain disease and had a subarachnoid hemorrhage due to a ruptured aneurysm.
Who may be able to join
- ①18-80 years old; ② Voluntary patients with spontaneous subarachnoid hemorrhage undergoing aneurysm interventional therapy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yuanjian Fang, MD, 87784815, Sandman0506@zju.edu.cn
About this study
Official title: Radiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Spontaneous Subarachnoid Hemorrhage
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.
Read the detailed 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.
- Being tested
- subarachnoid hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage, Lymphatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subarachnoid hemorrhageDiagnostic test
CT presented subarachnoid hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Ruptured aneurysm | Patients with aneurysmal subarachnoid hemorrhage Receives: Diagnostic Test: subarachnoid hemorrhage | |
| Unruptured aneurysm | Patients with unruptured aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 7 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 May 2024
- Primary completion20 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444438
- Sponsor's protocol ID
- 2024-0224
- Status last verified
- Mar 2024
- First submitted
- 31 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Spontaneous Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06444438
- Acronym / sponsor ID
- 2024-0224
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 5 Jun 2024 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruptured aneurysm | – | Diagnostic Test: subarachnoid hemorrhagePatients with aneurysmal subarachnoid hemorrhage |
| Unruptured aneurysm | – | –Patients with unruptured aneurysm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient had no prior brain disease and had a subarachnoid hemorrhage due to a ruptured aneurysm.
Key inclusion criteria (1 listed)
- ①18-80 years old; ② Voluntary patients with spontaneous subarachnoid hemorrhage undergoing aneurysm interventional therapy.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subarachnoid hemorrhageCT presented subarachnoid hemorrhage | Diagnostic test | Ruptured aneurysm |
Primary outcome
The drainage function of the glymphatic system - meningeal lymphatic vessels
Time frame: Within 7 days after admission
The drainage function of the lgymphatic system - meningeal lymphatic vessels was observed by magnetic resonance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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. This study is not recruiting at the moment.
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 Hemorrhage and Lymphatic System Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The drainage function of the glymphatic system - meningeal lymphatic vessels (time frame: Within 7 days after admission). 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 5 Jun 2024.