Chronic Subdural Hematoma, Recurrence
Conditions
Keywords
Chronic Subdural Hematoma, body posture, intracranial pressure
Brief summary
This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
Detailed description
The BP-CSDH study is a prospective, multicentre, open-label, randomised controlled trial with blinded endpoint assessment. 830 eligible patients will be randomised 1:1 to body posture therapy group or the control group. Follow-up assessments will be conducted at 30 days (±7 days), 90 days (±10 days) and 365 days(±30 days) post-surgery.
Interventions
BEHAVIORALIntracranial Hypotension Targeted(IHT) Body Posture
IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head.For patients with unilateral CSDH, the head should be tilted towards the hematoma affected side and opposite side lying should be avoided as much as possible. For patients with bilateral CSDH, there is no need for the head lateralization.To avoid food reflux and aspiration pneumonia, IHT therapy was strictly prohibited within 2 hours after each meal
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm; 2. more than 60 years of age or 60 years; 3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal 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
1. have brain hernia or acute massive cerebral infarction that have to perform craniotomy 2. have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance; 3. Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence 4. Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery. 5. 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; 6. CSDH persisting for over 1 year and exhibiting marked organization/solidification of the 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. Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage; 10. have deep venous thrombosis of lower extremity or pulmonary embolism; 11. cannot complete regular reexamine within 1 year for any reason; 12. life expectancy less than 1 year; 13. participating other ongoing clinical trial; 14. patients are not qualified for other reason evaluated by two neurosurgeons; 15. have bile reflux gastritis and esophageal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| subdural hematoma recurrence rate | within 90±10 days post-surgery | Hematoma recurrence was defined as the presence of symptoms attributable to subdural hematoma after surgery, accompanied by a maximum hematoma thickness exceeding 10 mm on imaging, excluding hemorrhage caused by new head trauma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in modified Rankin Scale(mRS) compared to baseline | 90±10 days post-surgery | The mRS is a clinician-reported measure of global disability,ranging from 0 to 6, with higher scores indicating more severe disability |
| change in EQ-5D-5L score compared to baseline | 90±10 days post-surgery | The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status |
| change in MGS-GCS score compared to baseline | 90±10 days post-surgery | The MGS-GCS is used to assess the severity of clinical symptoms and consciousness status. |
Countries
China
Contacts
CONTACTXuehai Wu, Ph.D.
PRINCIPAL_INVESTIGATORXuehai Wu, Ph.D.
Department of Neurosurgery, Huashan Hospital, Fudan University
PRINCIPAL_INVESTIGATORying mao, Ph.D.
Department of Neurosurgery, Huashan Hospital, Fudan University
Outcome results
None listed