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

NCT ID: NCT00915928

Last Updated: 2020-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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

Conditions

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Hematoma, Subdural, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACE inhibitor

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

Group Type ACTIVE_COMPARATOR

Perindopril

Intervention Type DRUG

2,5 mg daily for 3 months

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo dayli for 3 months

Interventions

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Perindopril

2,5 mg daily for 3 months

Intervention Type DRUG

Placebo

Placebo dayli for 3 months

Intervention Type DRUG

Other Intervention Names

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coversyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alice Brenaa Foundation

OTHER

Sponsor Role collaborator

The Hede Nielsen Family Foundation

OTHER

Sponsor Role collaborator

Overlægerådets legatudvalg

UNKNOWN

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frantz Rom Poulsen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frantz R Poulsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Odense University Hospital

Other Identifiers

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Eudra CT nummer 2009-010058-37

Identifier Type: -

Identifier Source: secondary_id

Chronic Subdural Hematoma

Identifier Type: -

Identifier Source: org_study_id

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