Safe Implementation of Thrombolysis in Stroke Monitoring Study "SITS-MOST"

Completed

Phase N/A Results

Trial Description

To compare the safety and efficacy of tissue plasminogen activator (TPA) administered in controlled clinical trials to that of TPA prescribed in routine clinical practice.

Interventions

Trial Design

Non-controlled, observational study comparing outcomes of non-study patients to those participating in a controlled clinical trial.

Patient Involvement

Patients are treated according to their clinician's discretion. Physicians who wish to add eligible patients to the registry will supply information regarding the times of onset of stroke, CT scan, and TPA thrombolysis, the patient's gender, prestroke MRS score, the presence of any risk factors (e.g. hypertension, diabetes mellitus, smoking, etc), the patient's stroke subtype, any pretreatment CT, MRI, or transcranial Doppler results, the pretreatment and 24-hour posttreatment NIH Stroke Scale (NIHSS) scores, and stroke etiology. They will also fill out an "outcomes" form reporting CT results at 24-48 hours posttreatment, hemorrhagic complications, mortality, adverse events and 3-month MRS score. These data describing the circumstances of admission and treatment, stroke etiology, and outcome will be compared to results gathered in the treatment arms of controlled clinical trials of TPA.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death, symptomatic intracranial hemorrhage (SICH), parenchymatous hemorrhage (PH2), disability (defined by a modified Rankin score (MRS) > 2).

Sponsors

Boehringer Ingelheim GmbH