NCT04607447

Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
BEHAVIORAL	low intracranial pressure strategy treatment	1. Supine position for 16h-18h daily, with head toward the affected side in most of the time, and 15-20 cm elevation of lower limbs. 2. Abdominal belt compression
DRUG	Atorvastatin plus Dexamethasone	Atorvastatin plus Dexamethasone

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-08-01
• Completion: 2023-12-30
• First posted: 2020-10-29
• Last updated: 2020-11-10

Locations

1 site across 1 country: China