Official Title

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

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    perindopril ...
  • Study Participants

    47
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 Started
Jul 31
2009
Primary Completion
May 31
2012
Study Completion
Jun 30
2012
Results Posted
Aug 19
2020
Last Update
Aug 19
2020

Drug Perindopril

2,5 mg daily for 3 months

  • Other names: coversyl

Drug Placebo

Placebo dayli for 3 months

ACE inhibitor Active Comparator

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

Placebo Placebo Comparator

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

Criteria

Inclusion Criteria:

Patients with chronic subdural hematoma that needs surgical evacuation
Age > 18 year

Exclusion Criteria:

Lack of compliance
Kidney artery stenosis
Stenosis of the aorta
Severely decreased kidney function
Allergy or intolerance/contraindications toward ACE inhibitors
Already in ACE inhibitor treatment
Coagulopathies
Malignant disorders
Fertile women
Other neurological disorders
Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors

Summary

ACE Inhibitor

Placebo

All Events

Event Type Organ System Event Term

Size of Chronic Subdural Hematoma (CSDH)

Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

ACE Inhibitor

28.4
cm^3 (Mean)
Standard Deviation: 5

Placebo

22.8
cm^3 (Mean)
Standard Deviation: 5

Composition of Chronic Subdural Hematoma Fluid

Post-Hoc Outcome Measure

Composition of Chronic Subdural Hematoma Fluid

Total

47
Participants

Age, Continuous

67.2
years (Mean)
Standard Deviation: 5

Size of Chronic Subdural Hematoma

127
cm^3 (Mean)
Standard Deviation: 10

Region of Enrollment

Sex: Female, Male

Overall Study

ACE Inhibitor

Placebo