Efficacy of Atorvastatin in Chronic Subdural Haematoma

Chronic Subdural Hematoma Clinical Trial

— REACH  

Official title:

A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03956368
• Other study ID #: REACH-v1
• Status: Recruiting
• Phase: Phase 3
• Start date: January 9, 2020
• Est. completion date: March 16, 2023

Study information

• Verified date: November 2021
• Source: Chinese University of Hong Kong
• Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg
• Phone: +852 3505 2624 / 3505 1522
• Email: poonws[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.

Description:

Objectives: Chronic subdural haematoma (CSDH) is a common neurosurgical condition in the elderly population associated with mild head injury. Surgical drainage has been regarded as safe and effective. However, surgical complications including recurrences can result in poor functional outcome and fatality, particularly in the elderly patients. Atorvastatin, an HMGCoA reductase inhibitor and a widely prescribed lipid lowering medication has properties of inflammation modulation and neovasculature promotion.

Hypothesis: Atorvastatin can improve functional outcome in patients with CSDH for both initially non-operatively treated group (estimated to be 10%) and the operative group (90%) by reducing the rate of surgical intervention and recurrence rate.

Design: A prospective multicentre study of 690 consented patients with symptomatic CSDH will be randomised on the day of admission to receive atorvastatin 20 mg or a placebo daily for 8 weeks. All seven regional neurosurgical units in Hong Kong and two units outside Hong Kong, each treating 80-200 patients per annum, have been invited to participate.

Main Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome:

surgical recurrence.

Sample Size: Assuming an absolute 10% improvement in favourable outcome in the Modified Rankin Scale score (mRS 0-3) at 6 months from the control group of 70% to the treatment group 80%, allowing a 10% loss to follow up, a sample size of 690 is required.

Expected Results: A successful study for improving clinical outcome of CSDH, an important illness of the elderly with an annual incidence of 58/100,000 will change clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 690
• Est. completion date: March 16, 2023
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18 years old;

2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);

3. Patients are joining the trial voluntarily with consent form signed.

Exclusion Criteria:

1. Allergy to atorvastatin or other statins;

2. Deranged liver function;

3. Patients who are already on long term steroid for other condition(s);

4. Patients who are already on statin for other condition(s);

5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);

6. Pregnant or on breast feeding;

7. Hematoma is secondary to tumour or haematological disorders;

8. Patients taking angiotensin converting enzyme (ACE) inhibitor.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Atorvastatin 20mg
20mg (every evening orally) for 8 weeks.
• Placebos
20mg (every evening orally) for 8 weeks.

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Chai Wan
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Kwong Wah Hospital	Kowloon
Hong Kong	Princess Margaret Hospital	Kowloon
Hong Kong	Queen Elizabeth Hospital	Kowloon
Hong Kong	Prince of Wales Hospital	Shatin	New Territories
Hong Kong	Tuen Mun Hospital	Tuen Mun

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glasgow Outcome Scale (GOS)	Gross clinical outcome measure which allows standardised descriptions (good recovery, moderate disability, severe disability, persistent vegetative state, and death, with good recovery indicating the best outcome and death indicating the worst) for the degree of recovery in patients with brain damage.	2 weeks, 8 weeks, 3 months, and 6 months
Other	Imaging diagnosis	Computed Tomography (CT) brain scan to exclude the presence of air and new blood in subdural space at 1-2 weeks and to elevate the clarification of CSDH resolution at 3 months and 6 months.	Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months
Other	Barthel Index (BI)	Ordinal scale used to measure performance in activities of daily living (ADL) which uses 10 variables describing ADL and mobility. Scores range from 0-100 with 0 indicating the worst outcome and 100 indicating the best outcome.	2 weeks, 8 weeks, 3 months, and 6 months
Other	Montreal Cognitive Assessment (MoCA)	One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.	2 weeks, 8 weeks, 3 months, and 6 months
Other	Modified Rankin Scale	Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.	2 weeks, 8 weeks, 3 months, and 6 months
Primary	Favourable Modified Rankin Scale (mRS) score	Modified Rankin Scale score of 0-3	6 months
Secondary	Chronic subdural haematoma (CSDH) related surgical intervention	Recurrence rate in both initially non-operatively treated patients and operative cases	Throughout the study period, an average of 6 months