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

Not Applicable

Terminated

• Conditions: Hematoma, Subdural, Chronic
• Interventions: Drug: Placebo; Drug: Perindopril

• Registration Number: NCT00915928
• Lead Sponsor: Odense University Hospital

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

Study Timeline

• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-08
• Study Start: 2009-07
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2020-08
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients randomized to this arm will be treated with placebo after surgery
ACE inhibitor	Perindopril	patients randomized to this arm will be treated with ACE inhibitors after surgery

Primary Outcome Measures

Name	Time	Method
Size of Chronic Subdural Hematoma (CSDH)	3 months	Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

Secondary Outcome Measures

Name	Time	Method
Composition of Chronic Subdural Hematoma Fluid	years	Post-Hoc Outcome Measure