Hematoma, Subdural, Chronic
Conditions
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
Interventions
DRUGPerindopril
2,5 mg daily for 3 months
DRUGPlacebo
Placebo dayli for 3 months
Sponsors
Alice Brenaa Foundation
The Hede Nielsen Family Foundation
Overlægerådets legatudvalg
University of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of Chronic Subdural Hematoma (CSDH) | 3 months | Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composition of Chronic Subdural Hematoma Fluid | years | Post-Hoc Outcome Measure |
Participant flow
Recruitment details
Neurosurgical clinic
Participants by arm
| Arm | Count |
|---|---|
| Placebo three months placebo treatment after surgical CSDH evacuation | 22 |
| Perindopril three months perindopril treatment after surgical CSDH evacuation | 25 |
| Total | 47 |
Baseline characteristics
| Characteristic | Total | Placebo | Perindopril |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 5 | 70.5 years STANDARD_DEVIATION 5 | 64.3 years STANDARD_DEVIATION 5 |
| Region of Enrollment Denmark | 47 participants | 22 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 38 Participants | 17 Participants | 21 Participants |
| Size of Chronic Subdural Hematoma | 127 cm^3 STANDARD_DEVIATION 10 | 130 cm^3 STANDARD_DEVIATION 10 | 124 cm^3 STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 22 |
| other Total, other adverse events | 0 / 25 | 0 / 22 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 |
Outcome results
Primary
Size of Chronic Subdural Hematoma (CSDH)
Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACE Inhibitor | Size of Chronic Subdural Hematoma (CSDH) | 28.4 cm^3 | Standard Deviation 5 |
| Placebo | Size of Chronic Subdural Hematoma (CSDH) | 22.8 cm^3 | Standard Deviation 5 |
Secondary
Composition of Chronic Subdural Hematoma Fluid
Post-Hoc Outcome Measure
Time frame: years
Population: Analysis will not be performed due to insufficient funding and the samples will be destroyed