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Efficacy of Atorvastatin in Chronic Subdural Haematoma

NCT ID: NCT03956368

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2023-03-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Subdural Hematoma

Keywords

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Chronic subdural haematoma Medical treatment Atorvastatin Clinical outcome Surgical recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group

Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.

Group Type EXPERIMENTAL

Atorvastatin 20mg

Intervention Type DRUG

20mg (every evening orally) for 8 weeks.

Control Group

Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

20mg (every evening orally) for 8 weeks.

Interventions

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Atorvastatin 20mg

20mg (every evening orally) for 8 weeks.

Intervention Type DRUG

Placebos

20mg (every evening orally) for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Prof. Wai Sang Poon

Chair Professor & Chief in Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Site Status RECRUITING

Pamela Youde Nethersole Eastern Hospital

Chai Wan, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Kwong Wah Hospital

Kowloon, , Hong Kong

Site Status RECRUITING

Princess Margaret Hospital

Kowloon, , Hong Kong

Site Status RECRUITING

Queen Elizabeth Hospital

Kowloon, , Hong Kong

Site Status RECRUITING

Tuen Mun Hospital

Tuenmen, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg

Role: CONTACT

Phone: +852 3505 2624 / 3505 1522

Email: [email protected]

Facility Contacts

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Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg

Role: primary

Shing Kit Chan, MBBS, MRCS(Ed), MHKICBSC

Role: primary

(Site PI) Anderson Chun On Tsang, MBBS(Hons),MHKICBSC,MRCS(Ed)

Role: primary

(Site PI) Peter Yat Ming Woo, MBBS,MMedSc,FRCS,FCSHK,FHKAM

Role: primary

(Site PI) Kwan Ho Chow, MBChB,HKICBS,FCSHK

Role: primary

(Site PI) Calvin Hoi Kwan Mak, MBBS,MRCS,FRCSEd(SN),FHKAM

Role: primary

(Site PI) Jason Man Kit Ho, MBChB (CUHK)

Role: primary

Other Identifiers

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REACH-v1

Identifier Type: -

Identifier Source: org_study_id