Seeing if antibiotics given after surgery reduce recurrence of chronic subdural hematoma
Official title: Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
Run by University of Rostock · NCT07556991 · Data updated 2026-11-12
This trial will test whether a short course of amoxicillin‑clavulanate given after surgery can lower the chance of chronic subdural hematoma coming back in adults.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | University of Rostock Academic / other |
| Locations | 1 site (Rostock) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07556991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 undergoing surgical treatment for a first‑time chronic subdural hematoma who are not currently on antibiotics and have no active infection.
✕Probably not a fit
Patients with recurrent hematomas, those treated conservatively (non‑surgically), or those already receiving antibiotics or with active infections are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, interventional Phase 2/3 trial enrolling adults (>18) who undergo surgical treatment for chronic subdural hematoma. Participants are randomized to receive either amoxicillin‑clavulanic acid or placebo after surgery and are followed for hematoma recurrence and related clinical outcomes. Key exclusion criteria include current or recent antibiotic treatment, active infection, recurrent cSDH, and patients managed conservatively without surgery. The trial is conducted at the University Medical Center Rostock as a single‑center effort.
Why it matters
Potential benefit: If successful, a short postoperative course of antibiotics could reduce recurrence and the need for repeat surgery in patients with chronic subdural hematoma.
How similar studies have gone: This is a relatively novel approach: retrospective reports suggest possible low‑grade infection in recurrent cases, but randomized controlled evidence is currently lacking.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UnIversity Medical Center Rostock
Rostock, Germany Recruiting
Study contacts
- Study coordinator: Daniel PD Dr.med.habil. Dubinski, MD MSc
- Email: daniel.dubinski@med.uni-rostock.de
- Phone: +49 381 494 6439
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma
This study tests whether safely coagulating small branches of the middle meningeal artery during burr-hole drainage can reduce recurrence of chronic subdural haematoma in adults receiving standard surgical care.
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Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients
This project tests whether an enhanced recovery protocol for adults having burr-hole drainage for chronic subdural hematoma can reduce recurrence and complications compared with past patients.
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Embolization of the middle meningeal artery for treating chronic subdural hematomas
This study is testing if blocking a specific artery can help people with chronic subdural hematomas either when combined with surgery or as a standalone treatment for those who can’t have surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.