Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma. (iSDH)
Sponsor: University of Rostock
This observational or N/A phase trial investigates Chronic Subdural Hematomas and is currently actively recruiting participants. University of Rostock leads this study, which shows 1 recorded version since 2024 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
1 version recordedEligibility Summary
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, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown. The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.
Contact Information
- University of Rostock
For direct contact, visit the study record on ClinicalTrials.gov .