NCT07556991 Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
| NCT ID | NCT07556991 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Rostock |
| Condition | Chronic Subdural Hematomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 164 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07556991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07556991 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07556991 currently recruiting?
Yes, NCT07556991 is actively recruiting participants. Contact the research team at daniel.dubinski@med.uni-rostock.de for enrollment information.
Where is the NCT07556991 trial being conducted?
This trial is being conducted at Rostock, Germany.
Who is sponsoring the NCT07556991 clinical trial?
NCT07556991 is sponsored by University of Rostock. The trial plans to enroll 164 participants.