Subdural Hematoma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>18 years of age

• surgical treatment of chronic subdural hematoma

Locations
Other Locations
Germany
UnIversity Medical Center Rostock
RECRUITING
Rostock
Contact Information
Primary
Daniel PD Dr.med.habil. Dubinski, MD MSc
daniel.dubinski@med.uni-rostock.de
+49 381 494 6439
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 164
Treatments
Experimental: Antibiotic Arm
Treatment with oral antibiotics for 10 days after surgical treatment
Placebo_comparator: Placebo group
Placebo oral drug administration 10 days after surgical treatment
Sponsors
Leads: University of Rostock

This content was sourced from clinicaltrials.gov