NCT06401772

The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 830 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.

Conditions

• Chronic Subdural Hematoma
• Recurrence

Interventions

Type	Name	Description
BEHAVIORAL	Intracranial 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

Timeline

• Start date: 2024-08-08
• Primary completion: 2026-12-01
• Completion: 2028-01-01
• First posted: 2024-05-07
• Last updated: 2024-11-19

Locations

1 site across 1 country: China