Text Size

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

This study is currently recruiting participants.
Verified July 2011 by Odense University Hospital
Sponsor:
Collaborators:
Alice Brenaa Foundation
Hede Nielsen Foundation
Overlægerådets legatudvalg
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00915928
First received: June 3, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Recurrence of chronic subdural hematoma after surgical removal [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composition of chronic subdural hematoma fluid [ Time Frame: Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2009
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915928

Contacts
Contact: Frantz Rom Poulsen, MD, PhD +45 25306791 frantzrom@hotmail.com
Contact: Morten Søe, MD +45 66113333 MOS28.OUH-POST1@ouh.fyns-amt.dk

Locations
Denmark
Department of Neurosurgery, Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Morten Søe, MD     +45 66113333     MOS28.OUH-POST1@ouh.fyns-amt.dk    
Principal Investigator: Frantz Rom Poulsen, MD, PhD            
Sub-Investigator: Morten Søe, MD            
Sub-Investigator: Sune Munthe, MD            
Sponsors and Collaborators
Odense University Hospital
Alice Brenaa Foundation
Hede Nielsen Foundation
Overlægerådets legatudvalg
University of Southern Denmark
Investigators
Principal Investigator: Frantz Rom Poulsen, MD, PhD Department of Neurosurgery, Odense University Hospital
  More Information

No publications provided

Responsible Party: Frantz Rom Poulsen, MD, PhD, Department of Neurosurgery, Odense University Hospital, Odense, Denmark
ClinicalTrials.gov Identifier: NCT00915928     History of Changes
Other Study ID Numbers: Chronic Subdural Hematoma, Eudra CT nummer 2009-010058-37
Study First Received: June 3, 2009
Last Updated: July 22, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Recurrence
Hemorrhage
Pathologic Processes
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
Disease Attributes
Angiotensin-Converting Enzyme Inhibitors
Perindopril
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013