Clinical Trial: Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

Brief Summary: To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

Detailed Summary:

Study design:

Multi-center, randomized, double-blind, placebo parallel controlled

Subjects:

Patients with chronic subdural hematoma (CSDH)

Sample size:

200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.


Sponsor: Oriental Neurosurgery Evidence-Based-Study Team

Current Primary Outcome: Hematoma Reduced Amount. [ Time Frame: Check on 8 weeks during treatment (at the end) ]

The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  • Changes of neurological symptoms and signs [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  • Changes of routine blood test and coagulation results [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  • Hematoma Reduced Amount [ Time Frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks. ]


Original Secondary Outcome:

  • The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 3 and 6 months. ]
  • Changes of neurological symptoms and signs [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 3 and 6 months. ]
  • Changes of routine blood test and coagulation results [ Time Frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 3 and 6 months. ]


Information By: Oriental Neurosurgery Evidence-Based-Study Team

Dates:
Date Received: August 7, 2013
Date Started: December 2013
Date Completion:
Last Updated: October 24, 2016
Last Verified: February 2016