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

NCT07129603 | Recruiting DMC

• 3 other identifiers: AITT 2024/3NNGYK/14357-2/2025DE RKEB/IKEB 6947-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background Non-traumatic subarachnoid haemorrhage (SAH) is frequently complicated by delayed cerebral ischaemia (DCI) and by ventriculitis/meningitis when external CSF drains are used; bedside TCCD has limited accuracy for vasospasm detection, creating a need for early biomarkers. Objective To assess the predictive and diagnostic performance of IL-6, IL-1β, TNFα, procalcitonin (PCT), C-reactive protein (CRP) and adrenomedullin (ADM) measured in CSF and serum for vasospasm, DCI, and drain-associated ventriculitis/meningitis after SAH; to test whether combining biomarkers improves accuracy versus routine parameters; and to explore associations with admission and day-14 serum 25-hydroxy-vitamin D. Methods Prospective case-control study at the University of Debrecen (planned n≈100; enrolment 01-Nov-2024-31-Dec-2029). Adults with angiography-verified SAH requiring lumbar/ventricular drainage are included; traumatic SAH, prior 6-month meningitis, and immunosuppression are excluded. TCCD is performed daily for 14 days; suspected vasospasm is defined by mean flow velocity \>120 cm/s, severe by \>200 cm/s, with monitoring extended to day 21 if severe. Sampling: daily CSF IL-6/PCT/CRP until drain removal; IL-1β/TNFα/ADM at 0-2, 3-5, 6-8, 9-11, 12-14 days and at meningitis detection; serum 25-OH-D on drain insertion day and day 14. Outcomes at days 30/90/180: mortality, GOSE, Barthel, Karnofsky, mRS. Statistics: normality testing; t-test or non-parametric equivalents; χ² with Yates' correction; Bonferroni for multiplicity; ROC analysis for diagnostic/predictive performance. Endpoints DCI: new unexplained CT ischaemia or a new unexplained neurological deficit \>1 h. Drain-associated infection: infectologist-adjudicated ventriculitis/meningitis. Vasospasm: TCCD-suggested or DSA-confirmed. Expected impact An accessible CSF/serum biomarker panel may enable earlier risk stratification and treatment for vasospasm, DCI, and drain-associated infections, and inform future randomized trials of vitamin-D supplementation in SAH.

Conditions

Subarachnoid Haemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• DCI

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) admitted to the Neurosurgical Intensive Care Unit of the University of Debrecen Clinical Centre with non-traumatic subarachnoid haemorrhage (SAH) who, as part of standard care, require external CSF drainage (lumbar or ventricular). Patients are treated per local protocol and monitored with routine severity scales (modified Fisher, Hunt-Hess, WFNS, GCS, VASOGRADE, HAIR). Key exclusions are traumatic SAH, lack of consent, meningitis within the prior 6 months, and clinically relevant immunosuppression. Approximately 100 consecutive eligible patients will be enrolled during the acute hospitalization over the planned inclusion window. The cohort reflects the typical SAH case-mix (both sexes, many critically ill; SAH commonly affects middle-aged adults) and is designed to capture patients at risk for vasospasm, delayed cerebral ischaemia and drain-associated ventriculitis/meningitis under ICU conditions.

You may qualify if:

• Adults (≥18 years).
• Angiography-identifiable non-traumatic SAH (regardless of source).
• Requires lumbar or ventricular drain as part of treatment.

You may not qualify if:

• Traumatic SAH.
• Patient/legal representative does not consent.
• Meningitis within 6 months prior to ictus.
• Immunosuppressed state (disease or medications affecting WBC number/function).

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

RECRUITING

Study Officials

• Csilla Molnár, MD PhD Full Professor

  University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Csilla Molnár, MD PhD Full Professor

CONTACT

+36302998097; csmolnar@med.unideb.hu

Dorottya Szántó, MD

CONTACT

+36309990718; szanto.dorottya@med.unideb.hu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 19, 2025

Record last verified: 2025-04

Locations

HU (1)