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

This study has been terminated.
(No effect of the ACE inhibitor evaluated halfway in the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915928
First Posted: June 8, 2009
Last Update Posted: April 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Alice Brenaa Foundation
Hede Nielsen Foundation
Overlægerådets legatudvalg
University of Southern Denmark
Information provided by (Responsible Party):
Frantz Rom Poulsen, Odense University Hospital
  Purpose
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.

Condition Intervention
Hematoma, Subdural, Chronic Drug: Perindopril Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

Resource links provided by NLM:


Further study details as provided by Frantz Rom Poulsen, Odense University Hospital:

Primary Outcome Measures:
  • Recurrence of chronic subdural hematoma after surgical removal [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Composition of chronic subdural hematoma fluid [ Time Frame: Months ]

Enrollment: 47
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACE inhibitor Drug: Perindopril
2,5 mg daily for 3 months
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915928


Sponsors and Collaborators
Odense University Hospital
Alice Brenaa Foundation
Hede Nielsen Foundation
Overlægerådets legatudvalg
University of Southern Denmark
Investigators
Principal Investigator: Frantz R Poulsen, MD, PhD Department of Neurosurgery, Odense University Hospital
  More Information

Responsible Party: Frantz Rom Poulsen, MD PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00915928     History of Changes
Other Study ID Numbers: Chronic Subdural Hematoma
Eudra CT nummer 2009-010058-37
First Submitted: June 3, 2009
First Posted: June 8, 2009
Last Update Posted: April 8, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Recurrence
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Disease Attributes
Pathologic Processes
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Enzyme Inhibitors
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Antihypertensive Agents