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

Odense University Hospital47 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hematoma, Subdural, Chronic

Interventions

PerindoprilDRUG

2,5 mg daily for 3 months

PlaceboDRUG

Placebo dayli for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Composition of Chronic Subdural Hematoma Fluid

Post-Hoc Outcome Measure

Time frame: years

Data from ClinicalTrials.gov

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