The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter Randomized Controlled Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Department of Neurosurgery, Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xuehai Wu, Ph.D.
Wuxuehai2013@163.com
+8613764880571
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2028-01
Participants
Target number of participants: 830
Treatments
Experimental: body posture group
In-hospital protocol of Intracranial Hypotension Targeted(IHT) Body Posture~1. Upper body horizontal and lower limbs elevated 30°, except for postprandial 2 hours to prevent reflux;~2. For unilateral CSDH: Affected side lateral decubitus combined with intermittent supine positioning; Nonaffected side decubitus should be avoided;~3. For bilateral CSDH: No specific head position requirements;~4. Body posture therapy was initiated immediately after randomization and maintained for 14-18 hours daily.~5. Daily documentation of body posture therapy duration and bed rest time in diary cards.~Post-discharge: patients received stage-stratified body posture therapy education Month 1: Perform body posture therapy during bed rest, minimum 6 hours daily. Months 2-3: Based on 1 month CT/MRI:(1) Complete/near-complete hematoma resolution: Continue therapy ≥1 hour/day.~(2) Persistent significant subdural hematoma: Maintain therapy≥6 hours/day until Month 3.
No_intervention: control group
Patients will be required to keep supine position. In addition to body posture therapy, patients will receive treatment as same as body posture group.
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital