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

NCT00915928 | Terminated Results DMC

• 2 other identifiers: Chronic Subdural HematomaEudra CT nummer 2009-010058-37
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hematoma, Subdural, Chronic

Outcome Measures

Primary Outcomes (1)

• Size of Chronic Subdural Hematoma (CSDH)

  Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

  3 months

Secondary Outcomes (1)

• Composition of Chronic Subdural Hematoma Fluid

  years

Study Arms (2)

ACE inhibitor

ACTIVE COMPARATOR

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

Drug: Perindopril

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Perindopril DRUG

2,5 mg daily for 3 months

Also known as: coversyl

ACE inhibitor

Placebo DRUG

Placebo dayli for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic subdural hematoma that needs surgical evacuation
• Age \> 18 year

You may not qualify if:

• Lack of compliance
• Kidney artery stenosis
• Stenosis of the aorta
• Severely decreased kidney function
• Allergy or intolerance/contraindications toward ACE inhibitors
• Already in ACE inhibitor treatment
• Coagulopathies
• Malignant disorders
• Fertile women
• Other neurological disorders
• Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors

Sponsors & Collaborators

• Odense University Hospital: lead
• Alice Brenaa Foundation: collaborator
• The Hede Nielsen Family Foundation: collaborator
• Overlægerådets legatudvalg: collaborator
• University of Southern Denmark: collaborator

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Perindopril

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Frantz Rom Poulsen, Professor, consultant
• Organization: Odense University Hospital, Odense, Denmark

frantz.r.poulsen@rsyd.dk

0045 65413600

Study Officials

• Frantz R Poulsen, MD, PhD

  Department of Neurosurgery, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 8, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08