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Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors (KSDH)

Primary Purpose

Hematoma, Subdural, Chronic

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perindopril
Placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematoma, Subdural, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with chronic subdural hematoma that needs surgical evacuation
  2. Age > 18 year

Exclusion Criteria:

  1. Lack of compliance
  2. Kidney artery stenosis
  3. Stenosis of the aorta
  4. Severely decreased kidney function
  5. Allergy or intolerance/contraindications toward ACE inhibitors
  6. Already in ACE inhibitor treatment
  7. Coagulopathies
  8. Malignant disorders
  9. Fertile women
  10. Other neurological disorders
  11. Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    ACE inhibitor

    Placebo

    Arm Description

    patients randomized to this arm will be treated with ACE inhibitors after surgery

    patients randomized to this arm will be treated with placebo after surgery

    Outcomes

    Primary Outcome Measures

    Size of Chronic Subdural Hematoma (CSDH)
    Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

    Secondary Outcome Measures

    Composition of Chronic Subdural Hematoma Fluid
    Post-Hoc Outcome Measure

    Full Information

    First Posted
    June 3, 2009
    Last Updated
    August 18, 2020
    Sponsor
    Odense University Hospital
    Collaborators
    Alice Brenaa Foundation, Hede Nielsen Foundation, Overlægerådets legatudvalg, University of Southern Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00915928
    Brief Title
    Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
    Acronym
    KSDH
    Official Title
    Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    No effect of the ACE inhibitor evaluated halfway in the study
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Odense University Hospital
    Collaborators
    Alice Brenaa Foundation, Hede Nielsen Foundation, Overlægerådets legatudvalg, University of Southern Denmark

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.
    Detailed Description
    Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematoma, Subdural, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ACE inhibitor
    Arm Type
    Active Comparator
    Arm Description
    patients randomized to this arm will be treated with ACE inhibitors after surgery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    patients randomized to this arm will be treated with placebo after surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Perindopril
    Other Intervention Name(s)
    coversyl
    Intervention Description
    2,5 mg daily for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo dayli for 3 months
    Primary Outcome Measure Information:
    Title
    Size of Chronic Subdural Hematoma (CSDH)
    Description
    Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Composition of Chronic Subdural Hematoma Fluid
    Description
    Post-Hoc Outcome Measure
    Time Frame
    years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic subdural hematoma that needs surgical evacuation Age > 18 year Exclusion Criteria: Lack of compliance Kidney artery stenosis Stenosis of the aorta Severely decreased kidney function Allergy or intolerance/contraindications toward ACE inhibitors Already in ACE inhibitor treatment Coagulopathies Malignant disorders Fertile women Other neurological disorders Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frantz R Poulsen, MD, PhD
    Organizational Affiliation
    Department of Neurosurgery, Odense University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

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