Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness

Summary

Participation Requirements

Description

Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study: Cerebrolysin Group: Patients who are treated with Cerebrolysin; dosage, frequency a...

Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study: Cerebrolysin Group: Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization Control group: Patients who are not treated with Cerebrolysin Observation criteria: Signed Informed Consent Clinical diagnosis of acute ischemic stroke confirmed by imaging Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive No prior stroke No prior disability Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1) Reasonable expectation of successful follow-up (max. 100 days) The study follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE). In order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ICH E6 Guideline for Good Clinical Practice (GCP, Amendment R2, July 2015), the FDA Guidance for Industry on a Risk-based Approach to Monitoring, and the EMA reflection-paper on risk-based quality management in clinical trials.

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