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Recruiting Phase 2 2024-516701-22-00

Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration (ReSCInD)

Phase 2 – studying effectiveness and dosage
Conditions: Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration

Sponsor: Klinikum der Universitaet Muenchen AöR

trial.available_in: БГ
Overview
Trial status: Authorised All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement. The primary endpoint, IL-1 β concentration in the blood within 24±6 hrs after symptom onset, will be analyzed in the full analysis set, which comes as close as possible to the IIT principle. A mixed linear regression model is calculated with the IL-1 β value (at 24±6hrs & 3 d) as the dependent variable, the randomized group, the IL-1 β value at baseline & the time point, the interaction of time + group, as independent variables and the patient as a random effect.
Description
All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 36 participants
Interventions
Isotonische Kochsalzlösung
Drug
Pulmozyme 2.500 E./2,5 ml, Lösung für einen Vernebler
Drug
Locations 1
Germany (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
31.10.2024
Registry ID
2024-516701-22-00
Source
euclinicaltrials.eu
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