The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
Recruiting now · Not applicable
Conditions studied: Chronic Subdural Hematoma, Recurrence
In brief
This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
Key facts
- Study ID
- NCT06401772
- Run by
- Huashan Hospital
- People needed
- 830
- Starts
- 2024-08-08
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
- more than 60 years of age or 60 years;
- MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
- patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
- receive burr hole drainage;
- sign informed consent voluntarily.
You may not qualify if…
- have brain hernia or acute massive cerebral infarction that have to perform craniotomy
- have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
- Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
- Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
- Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;
- CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
- CSDH caused by over V-P shunting;
- during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
- Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
- have deep venous thrombosis of lower extremity or pulmonary embolism;
- cannot complete regular reexamine within 1 year for any reason;
- life expectancy less than 1 year;
- participating other ongoing clinical trial;
- patients are not qualified for other reason evaluated by two neurosurgeons;
- have bile reflux gastritis and esophageal diseases.
Where it is running
- Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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