Measuring inflammatory markers to detect vasospasm, delayed ischemia, and drain-related meningitis after non-traumatic subarachnoid hemorrhage
Official title: Investigation of the Role of Inflammatory Markers in the Early Detection of Cerebral Vasospasm, Delayed Cerebral Ischemia, and Meningitis Associated With External Cerebrospinal Fluid Drainage After Non-Traumatic Subarachnoid Hemorrhage - A Prospective Case-Control Study
Run by University of Debrecen · NCT07129603 · Data updated 2026-11-12
This project will test whether measuring specific inflammatory markers in cerebrospinal fluid and blood can help detect vasospasm, delayed cerebral ischemia, and drain-related meningitis early in adults treated for non-traumatic subarachnoid hemorrhage.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Debrecen Academic / other |
| Locations | 1 site (Debrecen) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT07129603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with angiography-verified non-traumatic subarachnoid hemorrhage who require lumbar or ventricular external CSF drainage and can consent (or have a legal representative who can consent) are the intended participants.
✕Probably not a fit
Patients without external CSF drains, those with traumatic SAH, recent meningitis, or significant immunosuppression are excluded and would not benefit from the study procedures or results.
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 single-center prospective case-control study at the University of Debrecen enrolling about 100 adults with angiography-confirmed non-traumatic subarachnoid hemorrhage who require external lumbar or ventricular drainage. Investigators will measure a panel of biomarkers (IL-6, IL-1β, TNFα, procalcitonin, CRP, and adrenomedullin) in CSF and serum at prespecified intervals and collect daily transcranial color-coded duplex (TCCD) data for up to 14–21 days. The study will compare biomarker levels to clinical outcomes (vasospasm, delayed cerebral ischemia, and drain-associated ventriculitis/meningitis) using diagnostic and predictive performance metrics and explore whether combining markers improves accuracy versus routine parameters. Outcomes including mortality and functional scales are collected at 30, 90, and 180 days, and serum 25-hydroxy-vitamin D is measured at baseline and day 14.
Why it matters
Potential benefit: If successful, this approach could identify patients at high risk earlier so clinicians can start treatment sooner and potentially reduce complications, disability, and death.
How similar studies have gone: Biomarker approaches for vasospasm and infection after SAH have been explored with mixed results and no widely adopted diagnostic panel yet, so this work builds on prior studies but addresses an unmet need.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years). * Angiography-identifiable non-traumatic SAH (regardless of source). * Requires lumbar or ventricular drain as part of treatment. Exclusion Criteria: * Traumatic SAH. * Patient/legal representative does not consent. * Meningitis within 6 months prior to ictus. * Immunosuppressed state (disease or medications affecting WBC number/function).
Where it's running
-
University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hungary Recruiting
Study contacts
- Principal investigator: Csilla Molnár, MD PhD Full Professor — University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care
- Study coordinator: Csilla Molnár, MD PhD Full Professor
- Email: csmolnar@med.unideb.hu
- Phone: +36302998097
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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.