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

Hematoma, Subdural, Chronic Clinical Trial

— KSDH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00915928
• Other study ID #: Chronic Subdural Hematoma
• Secondary ID: Eudra CT nummer
• Status: Terminated
• Phase: N/A
• Start date: July 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic
• Recurrence

Intervention

Drug:
• Perindopril
2,5 mg daily for 3 months
• Placebo
Placebo dayli for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Alice Brenaa Foundation, Hede Nielsen Foundation, Overlægerådets legatudvalg, University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of Chronic Subdural Hematoma (CSDH)	Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans	3 months
Secondary	Composition of Chronic Subdural Hematoma Fluid	Post-Hoc Outcome Measure	years