Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematoma, Subdural, Chronic
Intervention: Perindopril (Drug); Placebo (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s): Frantz R Poulsen, MD, PhD, Principal Investigator, Affiliation: Department of Neurosurgery, Odense University Hospital
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.
Clinical Details
Official title: Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Recurrence of chronic subdural hematoma after surgical removal
Secondary outcome: Composition of chronic subdural hematoma fluid
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2009
Last updated: April 7, 2014
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