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Efficacy of Atorvastatin in Chronic Subdural Haematoma (REACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956368
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Wai Sang Poon, Chinese University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Atorvastatin 20mg Drug: Placebos Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.
Drug: Atorvastatin 20mg
20mg (every evening orally) for 8 weeks.

Placebo Comparator: Control Group
Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.
Drug: Placebos
20mg (every evening orally) for 8 weeks.




Primary Outcome Measures :
  1. Favourable Modified Rankin Scale (mRS) score [ Time Frame: 6 months ]
    Modified Rankin Scale score of 0-3


Secondary Outcome Measures :
  1. Chronic subdural haematoma (CSDH) related surgical intervention [ Time Frame: Throughout the study period, an average of 6 months ]
    Recurrence rate in both initially non-operatively treated patients and operative cases


Other Outcome Measures:
  1. Glasgow Outcome Scale (GOS) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    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. Imaging diagnosis [ Time Frame: Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months ]
    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.

  3. Barthel Index (BI) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    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.

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.

  5. Modified Rankin Scale [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956368


Contacts
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Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg +852 3505 2624 / 3505 1522 poonws@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, New Territories, Hong Kong
Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg    +852 3505 2624 / 3505 1522    poonws@surgery.cuhk.edu.hk   
Principal Investigator: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg         
Sub-Investigator: David Yuen Chung Chan, MRCSEd         
Sub-Investigator: George Kwok Chu Wong, MBChB,MD,FRCSEd,FCSHK-Surg         
Sub-Investigator: Stephanie Chi Ping Ng, PhD         
Sub-Investigator: William B Goggins, ScD, SM         
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Prof. Wai Sang Poon, Chair Professor & Chief in Neurosurgery, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03956368    
Other Study ID Numbers: REACH-v1
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Wai Sang Poon, Chinese University of Hong Kong:
Chronic subdural haematoma
Medical treatment
Atorvastatin
Clinical outcome
Surgical recurrence
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors