The Role of Meningeal Lymphatic Vessels in the Absorption of Chronic Subdural Hematoma and Its Injury Mechanism

NCT05426889 | Unknown

• 1 other identifier: 2022-0219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematoma, Subdural, Chronic

Outcome Measures

Primary Outcomes (4)

• Magnetic resonance signal intensity of meningeal lymphatic vessels

  The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital

  The first day after admission

• Magnetic resonance signal intensity of meningeal lymphatic vessels

  The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital

  3 days after surgery

• Magnetic resonance signal intensity of meningeal lymphatic vessels

  The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital

  1 months after surgery

• Magnetic resonance signal intensity of meningeal lymphatic vessels

  The signal intensity of meningeal lymphatic vessels was measured by PACS system in hospital

  6 months after surgery

Study Arms (2)

Surgical

OTHER

undergo surgery

Procedure: subdural hematoma burr hole drainage

non-surgical groups

OTHER

no surgery

Drug: drug conservative treatment

Interventions

subdural hematoma burr hole drainage PROCEDURE

For patients with larger hematoma, remove the hematoma by burr hole drainage

Surgical

drug conservative treatment DRUG

The patient did not receive surgical treatment and chose conservative treatment

non-surgical groups

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis chronic subdural hematoma
• Hematoma thickness greater than 10mm on imaging

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hosipital of zhejiang univerisity school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

sheng Chen, M.D.

CONTACT

saintchan@zju.edu.cn

sheng chen, M.D

CONTACT

+8613645814323

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 22, 2022
• Study Start: May 2, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)