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

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.

Study Overview

• Status: Terminated
• Conditions: Hematoma, Subdural, Chronic
• Intervention / Treatment: Drug: Perindopril; Drug: Placebo

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ACE inhibitor; patients randomized to this arm will be treated with ACE inhibitors after surgery	Drug: Perindopril; 2,5 mg daily for 3 months; Other Names: coversyl
Placebo Comparator: Placebo; patients randomized to this arm will be treated with placebo after surgery	Drug: Placebo; Placebo dayli for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of Chronic Subdural Hematoma (CSDH)	Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of Chronic Subdural Hematoma Fluid	Post-Hoc Outcome Measure	years

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark; Alice Brenaa Foundation; Hede Nielsen Foundation; Overlægerådets legatudvalg
• Investigators: Principal Investigator: Frantz R Poulsen, MD, PhD, Department of Neurosurgery, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 8, 2009

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Recurrence; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Perindopril
• Other Study ID Numbers: Chronic Subdural Hematoma; Eudra CT nummer 2009-010058-37