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
About this trial
This is an interventional treatment trial for Hematoma, Subdural, Chronic
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
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
NCT ID
NCT00915928
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
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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