Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration
Conditions
Brief summary
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.
Detailed description
All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.
Interventions
Sponsors
Klinikum der Universitaet Muenchen AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement. | — |
Countries
Germany
Outcome results
None listed