Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin plus Dexamethasone tablets | Active Comparator |
| |
| drugs+low intracranial pressure strategy treatment | Experimental | Drugs means treatment with Atorvastatin plus Dexamethasone tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low intracranial pressure strategy treatment | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| subdural hematoma volume | difference of hematoma volume in subdura between two groups | three months |
| Markwalder scale | difference of Markwalder scale between two groups;The Markwalder Scale is designed to measure the chronic subdural hematoma scale. This scale is categorized into four grade. Grade 0 denots the patient neurologically normal, whereas grade 4, the highest grade, denotes the worst neuological assessment. | three months |
| Modified Rankin Scale | difference of Modified Rankin Scale between two groups; The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. | three months |
| Extended Glasgow Outcome score | difference of Extended Glasgow Outcome score between two groups; This score is used to measure the outcome after neurological disease. It defines 5 categories of possible outcomes after a brain injury, which is from good recovery(5) to death(1). | three months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xuehai wu, phD | Contact | 8613764880571 | wuxuehai2013@163.com | |
| xiangru Ye, Master | Contact | 8618818210651 | xiangruye@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 5, 2023 | |
| Reset | Mar 15, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 5, 2023 | Mar 15, 2024 |
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atorvastatin plus Dexamethasone | Drug | Atorvastatin plus Dexamethasone |
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |