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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010058-37-DK

Enrollment

120

Registered

2009-02-26

Start date

2009-04-23

Completion date

Unknown

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Coversyl (perindopril) Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026