Related Experiment Video
Updated: Mar 30, 2026
A Low Mortality Rat Model to Assess Delayed Cerebral Vasospasm After Experimental Subarachnoid Hemorrhage
Published on: January 17, 2013
Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial
Rongcai Jiang1,2,3,4,5, Dong Wang6,7,8,9,10, Wai Sang Poon11
1Department of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.
Insights
This clinical trial investigates atorvastatin as a non-surgical treatment for chronic subdural hematoma (CSDH). The study aims to determine if atorvastatin effectively reduces CSDH volume and offers a safe alternative to surgery.
Area of Science:
- Neurosurgery
- Pharmacology
- Clinical Trials
Background:
- Chronic subdural hematoma (CSDH) is common in the elderly, with surgery having high recurrence rates.
- Aberrant angiogenesis and inflammation are implicated in CSDH development.
- Atorvastatin shows potential for non-surgical CSDH reduction due to its anti-inflammatory and pro-angiogenic properties.
Purpose of the Study:
- To evaluate the therapeutic efficacy and safety of oral atorvastatin in treating CSDH.
- To compare atorvastatin's effect on hematoma volume reduction against a placebo.
- To assess atorvastatin's impact on clinical outcomes and patient well-being.
Main Methods:
- Multi-center, randomized, placebo-controlled, double-blind clinical trial.
- 96 patients with confirmed CSDH randomized to atorvastatin (20 mg/night for 8 weeks) or placebo.
- Follow-up for 16 weeks, assessing primary outcome (hematoma volume change at 8 weeks) and secondary outcomes (clinical scales, functional status).
Main Results:
- Primary outcome: Change in hematoma volume at 8 weeks.
- Secondary outcomes: Hematoma volume at 4, 12, 24 weeks; Markwalder's Grading Scale, Glasgow Coma Scale, Glasgow Outcome Score, and Barthel Index.
- Safety assessment through adverse events, lab tests, ECG, and vital signs.
Conclusions:
- Results will determine if atorvastatin is an effective and safe non-surgical option for CSDH.
- Provides critical data for clinical decision-making in CSDH management.
- Contributes to evidence-based neurosurgical practice.
Background:
Chronic subdural hematoma (CSDH) is a common disease that is more prevalent in older people. Surgical intervention is a safe treatment of choice. However, the recurrence rate is relatively high and the outcome is not always satisfactory among surgically treated patients. It is believed that aberrant angiogenesis and intracapsular inflammation contribute to the development of CSDH. Atorvastatin is reported to promote angiogenesis and suppress inflammation. We have recently shown that atorvastatin is effective to non-surgically reduce and eliminate CSDH with minimal side effects. Here, we report a clinical research trial protocol that is designed to evaluate the therapeutic effects of atorvastatin on CSDH.
Methods/Design:
We have designed a multi-center, randomized, placebo-controlled, double blind clinical trial for evaluating the efficacy of oral atorvastatin in reducing CSDH. We have so far recruited 96 patients with CT-confirmed or MRI-confirmed CSDHs from 16 medical centers in China. These patients were originally recruited for the Oriental Neurosurgical Evidence-based Study Team (ONET) study. After informed consent is provided, patients are randomized to receive either atorvastatin (oral 20 mg/night for 8 weeks) or placebo (dextrin for 8 weeks); and followed for 16 weeks after the treatment. The primary outcome is the change in hematoma volume at the end of 8-week treatment. Secondary outcomes include: changes in 1) the hematoma volume at the 4(th), 12(th), and 24(th) weeks; 2) Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS); 3) Glasgow Outcome Score (GOS) and 4) Activities of Daily Life-the Barthel Index scale (ADL-BI). Safety will be assessed during the study by monitoring adverse events, laboratory tests, electrocardiography (ECG), measurements of vital signs (temperature, pulse, and blood pressure) and body weight.
Discussion:
Results of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.
Trial Registration:
ClinicalTrials.gov Identifier--NCT02024373 The date of trial registration: 7 August 2013.
More Related Videos
09:14Pre-Chiasmatic, Single Injection of Autologous Blood to Induce Experimental Subarachnoid Hemorrhage in a Rat Model
Published on: June 18, 2021
09:41Intrastriatal Injection of Autologous Blood or Clostridial Collagenase as Murine Models of Intracerebral Hemorrhage
Published on: July 3, 2014