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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematomas
• Intervention / Treatment: Drug: Amoxicillin + clavulanic acid; Drug: Placebo ( FE)

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Daniel PD Dr.med.habil. Dubinski, MD MSc; Phone Number: +49 381 494 6439; Email: daniel.dubinski@med.uni-rostock.de

Study Locations

• Germany
  • Rostock, Germany, 18057
    • Recruiting
    • University Medical Center Rostock
    • Contact: Daniel PD. Dr. med. habil. Dubinski, MD MSc; Phone Number: +49 381 494 6439; Email: daniel.dubinski@med.uni-rostock.de
    • Contact: Sae-Yeon Won, MD; Phone Number: +49 381 494 6439; Email: sae-yeon.won@med.uni-rostock.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic Arm; Treatment with oral antibiotics for 10 days after surgical treatment	Drug: Amoxicillin + clavulanic acid; 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 Comparator: Placebo group; Placebo oral drug administration 10 days after surgical treatment	Drug: Placebo ( FE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-operation within six 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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
type of bacterial colonisation	2weeks

Collaborators and Investigators

• Sponsor: University of Rostock

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Amides; Drug Combinations; Penicillin G; beta-Lactams; Lactams; Clavulanic Acid; Clavulanic Acids; Ampicillin; Penicillins; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: UMR2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No