Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration (ReSCInD)
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration
Спонсор: Klinikum der Universitaet Muenchen AöR
Налично на:
БГ
Обобщение
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.
Описание
All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.
Кой може да участва
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 36 participants
Интервенции
Isotonische Kochsalzlösung
Drug
Pulmozyme 2.500 E./2,5 ml, Lösung für einen Vernebler