Chronic subdural hematome - reduction of risc of recurrence by treatment with ACE inhibitors(in Danish: Kronisk subduralt hæmatom – reduktion af recidiv risiko ved behandling med ACE hæmmere)

Conditions: The project aims at investigating if treatment with the ACE inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematom will decrease the risc of recurrence.

Registration Number: EUCTR2009-010058-37-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1)Patients with chronic subdural hematome that needs surgical evacuation
2)age > 18 year

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate if treatment with the ACE inhibitor Coversyl (perindopril) will decrease the risc of recurrence of chronic subdural hematome following surgical hematome evacuation.;Secondary Objective: Analyse the hematome fluid and blood samples for growth factors and (if possible) by proteom analysis of patients with chronic subdural hematome;Primary end point(s): Patients treated surgically for chronic subdural hematome are subjected to CT scans of the head 1,5 and 3 months after surgery (earlier if needed). The primary end point is the size of the chronic subdural hematome at control scans.

Secondary Outcome Measures