NCT02192320

The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

Detailed description

Study design: Two-arm,Evaluator-blinded study Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted） Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
DRUG	Atorvastatin	20 mg (every evening orally) for 5 weeks
DRUG	Atorvastatin and Dexamethasone	Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-07-16
• Last updated: 2015-03-26

Locations

2 sites across 1 country: China