Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.

Recruiting Phase 2 Phase 3 Interventional Study
Chronic Subdural Hematomas
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
University of Rostock · Other
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About This Trial
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently,…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * \>18 years of age * surgical treatment of chronic subdural hematoma Exclusion Criteria: * prior or current antibiotic treatment * infection * recurrent chronic subdural hematoma * conservatively treated chronic subdural hematoma
Contacts

Daniel PD Dr.med.habil. Dubinski, MD MSc

+49 381 494 6439

daniel.dubinski@med.uni-rostock.de

CONTACT