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

Odense University Hospital

Status: Terminated

Conditions: Hematoma, Subdural, Chronic

Treatments: Drug: Placebo; Drug: Perindopril

Study type: Interventional

Funder types: Other

Identifiers

NCT00915928

Eudra CT nummer 2009-010058-37

Chronic Subdural Hematoma

Details and patient eligibility

About

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.

Full 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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

ACE inhibitor

Active Comparator group

Description:

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

Treatment:

Drug: Perindopril

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo