Overview

This trial has been completed.

Condition chronic subdural hematoma
Treatments atorvastatin, placebo
Phase phase 2
Sponsor Oriental Neurosurgery Evidence-Based-Study Team
Start date December 2013
End date April 2016
Trial size 200 participants
Trial identifier NCT02024373, CSDH2013

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
atorvastatin:20 mg (every evening orally) for 8 weeks
atorvastatin
20 mg (every evening orally) for 8 weeks
(Placebo Comparator)
placebo:20 mg (every evening orally) for 8 weeks
placebo
20 mg (every evening orally) for 8 weeks

Primary Outcomes

Measure
Hematoma Reduced Amount.
time frame: Check on 8 weeks during treatment (at the end)

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: 1. Age ≥ 18 and <90 years old, male or female; 2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); 3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3; 4. Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted; 5. Patients have never undergo surgery on the hematoma 6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent. Exclusion Criteria: 1. Allergic to the statin or its ingredients 2. Cerebral herniation might occur at any time; 3. Hematoma leads to herniation and warrants surgical operation. 4. Hematoma caused by tumors, blood and other known comorbidities; 5. Abnormal liver function 6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study 7. Patients have been on oral Statin treatment for a long time. 8. Patients have been on oral Steroids treatment for a long time. 9. Participate in clinical trials in the past four weeks; 10. Pregnant or breastfeeding 11. Failure of completing the trial by poor compliance; 12. For any reason, the researchers believe that the case is not suitable for inclusion.

Additional Information

Official title Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
Principal investigator Ning jian zhang, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Oriental Neurosurgery Evidence-Based-Study Team.