Efficacy of Atorvastatin in Chronic Subdural Haematoma

Last updated: November 19, 2021
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03956368
REACH-v1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age greater than or equal to 18 years old;
  2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) byComputed Tomography (CT);
  3. Patients are joining the trial voluntarily with consent form signed.

Exclusion

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.

Study Design

Total Participants: 690
Study Start date:
January 09, 2020
Estimated Completion Date:
March 16, 2023

Study 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.

Connect with a study center

  • Prince of Wales Hospital

    Shatin, New Territories
    Hong Kong

    Active - Recruiting

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Kwong Wah Hospital

    Kowloon,
    Hong Kong

    Active - Recruiting

  • Princess Margaret Hospital

    Kowloon,
    Hong Kong

    Active - Recruiting

  • Queen Elizabeth Hospital

    Kowloon,
    Hong Kong

    Active - Recruiting

  • Tuen Mun Hospital

    Tuen Mun,
    Hong Kong

    Active - Recruiting

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