The Role of Meningeal Lymphatic Vessels in the Absorption of Chronic Subdural Hematoma and Its Injury Mechanism
Primary Purpose
Hematoma, Subdural, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
subdural hematoma burr hole drainage
drug conservative treatment
Sponsored by
About this trial
This is an interventional screening trial for Hematoma, Subdural, Chronic
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis chronic subdural hematoma
- Hematoma thickness greater than 10mm on imaging
Exclusion Criteria:
- In patients with chronic subdural hematoma, only head CT examination was performed;
- There was previous brain injury (stroke, cerebral hemorrhage, etc., leaving relevant chronic changes on CT);
- Imaging data was lost and the onset of CSDH was accompanied by severe comorbidity disease patients.
Sites / Locations
- Second affiliated hosipital of zhejiang univerisity school of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Surgical
non-surgical groups
Arm Description
undergo surgery
no surgery
Outcomes
Primary Outcome Measures
Magnetic resonance signal intensity of meningeal lymphatic vessels
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Magnetic resonance signal intensity of meningeal lymphatic vessels
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Magnetic resonance signal intensity of meningeal lymphatic vessels
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Magnetic resonance signal intensity of meningeal lymphatic vessels
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Secondary Outcome Measures
Full Information
NCT ID
NCT05426889
First Posted
May 16, 2022
Last Updated
June 16, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05426889
Brief Title
The Role of Meningeal Lymphatic Vessels in the Absorption of Chronic Subdural Hematoma and Its Injury Mechanism
Official Title
Establishment of a Clinical Efficacy Prediction System Based on the Role of Meningeal Lymphatic Vessels in the Absorption of Chronic Subdural Hematoma and Its Injury Mechanism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Chronic subdural hematoma (CSDH) is a very common hemorrhagic disease of the nervous system, accounting for about 10% of hemorrhagic strokes. The incidence rate of elderly people over 65 years old is 58.1/100,000, and the incidence rate is increasing year by year, and it may reach 121/100,000 by 2030. At present, the specific pathogenesis of CSDH is still unclear. Although it has been clinically confirmed that a part of CSDH can be absorbed by itself, and some drugs such as atorvastatin can speed up the process, surgical treatments such as cranial craniotomy or cranial drilling hematoma removal are still the only options for patients with CSDH.
Lymphatic circulation spreads throughout most tissues of the human body, assists in removing metabolic wastes in the interstitium, maintains body fluid homeostasis, and plays a role in immune response and immune surveillance. For a long time, the central nervous system has been considered as an immune-privileged organ, that is, the central nervous system does not have the presence of the lymphatic system. Until 2015, Louveau et al. used immunofluorescence staining and other techniques to find functional lymphatic ducts adjacent to the dural venous sinuses in the mouse brain when looking for the channels for T cells to enter and leave the meninges, confirming the first intracranial meningeal lymphatic vessels. (mLVs), and found that mLVs express the classic markers of lymphatic endothelial cells (LECs), namely VEGFR3, prostate homeobox 1 (PROX 1), podoplanin, lymphatic endothelial markers transparent Ronidase receptor-1 (LYVE-1), etc. Relevant studies have confirmed that meningeal lymphatic vessels can drain interstitial fluid (ISF), macromolecular substances and immune cells out of the skull, providing a new drainage pathway for the excretion of metabolic waste from the central nervous system. Subsequent studies have confirmed that mLV is involved in the pathophysiological process of a series of neurological diseases such as Alzheimer's disease (AD), traumatic brain injury (TBI), and subarachnoid hemorrhage (SAH). This phenomenon suggests that mLVs play an important role in central nervous system diseases.
Detailed Description
Chronic subdural hematoma (CSDH) is a very common hemorrhagic disease of the nervous system, accounting for about 10% of hemorrhagic strokes. The incidence rate of elderly people over 65 years old is 58.1/100,000, and the incidence rate is increasing year by year, and it may reach 121/100,000 by 2030. At present, the specific pathogenesis of CSDH is still unclear. Although it has been clinically confirmed that a part of CSDH can be absorbed by itself, and some drugs such as atorvastatin can speed up the process, surgical treatments such as cranial craniotomy or cranial drilling hematoma removal are still the only options for patients with CSDH. However, these surgical methods have a high recurrence rate of hematoma and the incidence of surgery-related complications, which brings a huge burden to the patient's family and society. Despite the presence of a large number of inflammatory cytokines in the CSDH content, only a minority of patients exhibited systemic inflammatory responses such as fever and increased white blood cell count during hematoma resorption. On the contrary, more CSDH patients showed a certain degree of neurological deficit symptoms, such as hemiplegia of one limb and cognitive function decline. These clinical phenomena have stimulated thinking about how CSDH is drained. If the hematoma is absorbed through the vascular system, why is no corresponding inflammatory response or clinical symptoms observed in CSDH patients. In addition, the cerebrospinal fluid (CSF) of patients with CSDH was clear and the cell count was within the normal range, indicating that CSDH did not flow into the CSF. Therefore, further exploring the drainage pathway of CSDH, understanding the absorption process and recurrence mechanism of CSDH, and developing new effective treatment methods are important issues faced by neurosurgery clinicians.
Lymphatic circulation spreads throughout most tissues of the human body, assists in removing metabolic wastes in the interstitium, maintains body fluid homeostasis, and plays a role in immune response and immune surveillance. For a long time, the central nervous system has been considered as an immune-privileged organ, that is, the central nervous system does not have the presence of the lymphatic system. Until 2015, Louveau et al. used immunofluorescence staining and other techniques to find functional lymphatic ducts adjacent to the dural venous sinuses in the mouse brain when looking for the channels for T cells to enter and leave the meninges, confirming the first intracranial meningeal lymphatic vessels. (mLVs), and found that mLVs express the classic markers of lymphatic endothelial cells (LECs), namely VEGFR3, prostate homeobox 1 (PROX 1), podoplanin, lymphatic endothelial markers transparent Ronidase receptor-1 (LYVE-1), etc. Relevant studies have confirmed that meningeal lymphatic vessels can drain interstitial fluid (ISF), macromolecular substances and immune cells out of the skull, providing a new drainage pathway for the excretion of metabolic waste from the central nervous system. Subsequent studies have confirmed that mLV is involved in the pathophysiological process of a series of neurological diseases such as Alzheimer's disease (AD), traumatic brain injury (TBI), and subarachnoid hemorrhage (SAH). This phenomenon suggests that mLVs play an important role in central nervous system diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma, Subdural, Chronic
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical
Arm Type
Other
Arm Description
undergo surgery
Arm Title
non-surgical groups
Arm Type
Other
Arm Description
no surgery
Intervention Type
Procedure
Intervention Name(s)
subdural hematoma burr hole drainage
Intervention Description
For patients with larger hematoma, remove the hematoma by burr hole drainage
Intervention Type
Drug
Intervention Name(s)
drug conservative treatment
Intervention Description
The patient did not receive surgical treatment and chose conservative treatment
Primary Outcome Measure Information:
Title
Magnetic resonance signal intensity of meningeal lymphatic vessels
Description
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Time Frame
The first day after admission
Title
Magnetic resonance signal intensity of meningeal lymphatic vessels
Description
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Time Frame
3 days after surgery
Title
Magnetic resonance signal intensity of meningeal lymphatic vessels
Description
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Time Frame
1 months after surgery
Title
Magnetic resonance signal intensity of meningeal lymphatic vessels
Description
The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis chronic subdural hematoma
Hematoma thickness greater than 10mm on imaging
Exclusion Criteria:
In patients with chronic subdural hematoma, only head CT examination was performed;
There was previous brain injury (stroke, cerebral hemorrhage, etc., leaving relevant chronic changes on CT);
Imaging data was lost and the onset of CSDH was accompanied by severe comorbidity disease patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sheng Chen, M.D.
Email
saintchan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
sheng chen, M.D
Phone
+8613645814323
Facility Information:
Facility Name
Second affiliated hosipital of zhejiang univerisity school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sheng chen, M.D
Email
saintchan@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Meningeal Lymphatic Vessels in the Absorption of Chronic Subdural Hematoma and Its Injury Mechanism
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