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Clinical Associate Professor

Frantz Rom Poulsen

Department of Neurosurgery, Odense University Hospital

Projektstyring
Projektstatus Afsluttet (data er slettet/overført til Rigsarkivet, biologisk materiale er kasseret)
Data indsamlingsdatoer
Start 01.04.2009
Slut 01.04.2015
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere 52

Chronic subdural hematoma - does ACE inhibitors decrease the risk of recurrence

Short Summary

The purpose of this study is to examine the effect of Angiotensin Converting Enzyme treatment on the recurrence frequency after surgical removal of chronical subdural hematoma.

Rationale

Recurrence rates of between 5% and 25% have been reported following surgery for chronic subdural hematoma (CSH). A previous study showed that treatment with angiotensin converting enzyme (ACE) inhibitors decreases the risk of recurrence. To test the effects of ACE inhibitors on the recurrence CSH and CSH remnant six weeks after surgery, we conducted a prospective double-blinded randomized controlled clinical trial on patients with CSHs from July 2009 until October 2012. One of the most common acute and sub-acute neurosurgical problems is chronical subdural hematoma.

Description of the cohort

Patients (men and women >18 years old) eligible for burr hole surgery for CSH were randomized into either an ACE inhibitor perindopril 5 mg or placebo treatment daily for three months prior to surgery. Cerebral CT scans were performed after six weeks, and clinical follow-ups were performed three months after surgery. Additionally, a retrospective analysis of the data and CT scans from all non- randomized patients from the same time period was performed. The study is double blinded.

Data and biological material

CT-scans, chronic subdural hematoma fluid, blood samples.

Collaborating researchers and departments

Department of Neurosurgery, Odense University Hospital

Senior consultant, PhD Frantz Rom Poulsen, Senior consultant Morten Søe

Hospital Pharmacy, Odense University Hospital Department of Neurobiology Research

Institute of Molecular Medicine, University of Southern Demark

Professor Jens Zimmer

Department of Radiology in the Region of Southern Denmark

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