Analysis of triamcinolone levels in cerebrospinal fluid

Cerebrospinal fluid levels of triamcinolone acetonide - Triamcinolone in CSF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001863-60-AT

Enrollment

Registered

2019-07-02

Start date

2019-08-30

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this study triamcinolone acetonide levels after intratympanic application in the cerebrospinal fluid will be studied. Patients undergoing surgery with dura access will be asked to participate. Patients will receive triamcinolone acetonide applied intratympanically. During surgery a sample of cerebrospinal fluid will be recovered for analysis

Interventions

Trade Name: Volon A 40mg Pharmaceutical Form: Solution for injection INN or Proposed INN: TRIAMCINOLONE ACETONIDE Current Sponsor code: Triamcinolone acetonide Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients between 18 and 90 years, who are willing to participate in the study, will be included Patient who will undergo a surgery with opening of the dura and access to cerebrospinal fluid will be asked to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients younger than 18 years . Patients who receive cortison on a regular level or receive cortison i.v. or p.o. preoperatively . Patients with contraindications against the administration of Volon A

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective Demonstrate presence of Triamcinolone acetonide in cerebrospinal fluid ;Secondary Objective: Secondary Objectives • Correlation of timing of application with triamcinolone acetonide levels in cerebrospinal fluid • Assess the relationship of size of cochlear aqueduct (on CT) and triamcinolone level ;Primary end point(s): Levels of Triamcinolone acetonide in cerebrospinal fluid;Timepoint(s) of evaluation of this end point: At the end of the study the Triamcinolone acetonide levels will be determined in the cerebrospinal fluid.	—

Measure

Time frame

Main Objective: Primary Objective Demonstrate presence of Triamcinolone acetonide in cerebrospinal fluid ;Secondary Objective: Secondary Objectives • Correlation of timing of application with triamcinolone acetonide levels in cerebrospinal fluid • Assess the relationship of size of cochlear aqueduct (on CT) and triamcinolone level ;Primary end point(s): Levels of Triamcinolone acetonide in cerebrospinal fluid;Timepoint(s) of evaluation of this end point: At the end of the study the Triamcinolone acetonide levels will be determined in the cerebrospinal fluid.

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactHNO Ambulanz 8J

Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien

valerie.dahm@meduniwien.ac.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026