Measuring inflammatory markers to detect vasospasm, delayed ischemia, and drain-related meningitis after non-traumatic subarachnoid hemorrhage
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
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Debrecen Academic / other |
| Locations | 1 site (Debrecen) |
| Trial ID | NCT07129603 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Debrecen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.