chronic subdural hematoma
Conditions
Interventions
intervention group(body posture treatment group):Adopting posture therapy, the daily duration of posture therapy is 14-18 hours.
Control group:Routine postoperative positioning and treatment
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chronic subdural hematoma confirmed by cranial imaging (CT or MRI); hematoma thickness more than 1.0 cm. 2. more than 60 years of age or 60 years; 3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is 1 to 2; 4. 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; 5. receive burr hole drainage; 6. sign informed consent voluntarily;
Exclusion criteria
Exclusion criteria: 1. pregnancy or lactation; 2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy; 3. Patients with spinal diseases such as cervical spondylosis and kyphotic deformity,or mental illness, or conditions that require intubation or other monitoring treatment devices, or other disease unable to cooperate with long-term standardized body posture therapy; 4. Patients with brain tumors and brain aneurysms or vascular malformations. 5. CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery; 6. have CSDH for more than 1 year or organized hematoma; 7. CSDH caused by over V-P shunting; 8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia; 9. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly; 10. have venous thrombosis of lower extremity or pulmonary embolism; 11. cannot regular reexamine within 1 year for any reason; 12. participating other ongoing clinical trial; 13. Other ineligible conditions, such as multi-organ failure, which may aggravate patient's condition and impact follow-up; 14. have bile reflux gastritis and esophageal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of subdural pressure values and changes between the body posture therapy group and the control group after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate within 3 months after surgery;change in modified Rankin Scale(mRS) compared to baseline at 3 months after surgery;change in EQ-5D-5L score compared to baseline at 3 months after surgery;differences between two group in adverse events;compare the postoperative subdural hematoma drainage volume between the two groups.; | — |
Countries
China
Contacts
Public ContactWu Xuehai
Huashan Hospital, Fudan University
Outcome results
None listed