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NCT Number: NCT07556991

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin + clavulanic acid

Drug

Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.

Placebo ( FE)

Drug

Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.

Primary outcomes

  1. re-operation within six months

    Time frame: 6 months

    The primary objective is to determine if this postoperative antibiotic course reduces the rate of symptomatic cSDH recurrence requiring re-operation within six months. A pre-planned subgroup analysis will be conducted to compare outcomes specifically for patients with a positive microbiological culture versus those with a negative culture.

Secondary outcomes

  1. type of bacterial colonisation

    Time frame: 2weeks

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+49 381 494 6439

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Acronym: iSDH

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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