Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site

NCT07380477 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2025-01-15
Last updated
2026-02-02

Condition(s) studied

Acute Brain InjuryHydrocephalusExternal Ventricular DrainExternal Ventricular Drainage Associated Infection

Investigational drug(s) / intervention(s)

Sampling of blood and cerebrospinal fluid

Sampling of blood and cerebrospinal fluid: As soon as possible after placement of the external drain, and then in intervals of 1-3 days; * CSF analyses: cerebrospinal fluid group analysis (eosinophilic granulocytes, erythrocytes, glucose, nucleated cells, leucocytes (mononuclear), lymphocytes, macrophages, monocytes, neutrophil granulocytes, protein, and smudge cells) and lactate (L-lactate and D-lactate). Analyses will be performed by the Dept. of Biochemistry, Rigshospitalet, Denmark. * CSF microscopy and culture: Analysed by the Dept. of Microbiology, Rigshospitalet, Denmark. * Blood: C-reactive protein, differentials (leukocytes, neutrophile granulocytes, erythrocytes, lymphocytes). Analyses will be performed by the Dept. of Biochemistry, Rigshospitalet, Denmark. * Blood: lactate and glucose. Point of care (POC) analysis by blood gas analyser (Radiometer ABL800 Series Flex Q, Denmark)

Study summary

This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:

1. investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;
2. compare proximal and distal sample results obtained from an external ventricular drain;
3. describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>18 years * EVD in situ * Admission to the neuro-ICU or neurosurgical step-down unit at Rigshospitalet, Denmark * Diagnosis of acute brain injury categorized as traumatic brain injury, subarachnoid haemorrhage, intracranial haemorrage, intraventricular haemorrhage Exclusion Criteria: * Patient or closest relatives do not understand written and spoken Danish or English * Patients transferred to Rigshospitalet with an EVD * Patients with brain injury due to existing brain infection (e.g., meningitis, intracranial empyema or abscess, encephalitis) * Patients with existing ventriculoperitoneal or ventriculoatrial shunt at the time of admission * Patients with primary or secondary brain cancer * Patients died or in palliative care

Primary outcome measure(s)

  • Concentration of cerebrospinal fluid lactate — Throughout the external ventricular drain duration (1-60 days)
    in patients with compared to patients without positive CSF culture, and for b. patients with both a positive CSF culture and a distinct drop in the level of consciousness compared to patients with negative CSF culture and a stable level of consciousness.

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07380477 on ClinicalTrials.gov ↗ ← All trials in Denmark