Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Type of Adverse Event (Name of the adverse event). Measuring time: day 3, day 7, 1 month, 3 months. Duration ( Difference between the beginning and the end of the adverse effect). Measuring time: day 3, day 7, 1 month, 3 months. Intensity (Mild, moderate, severe). Measuring time: day 3, day 7, 1 month, 3 months. Severity (SerioUs/No serious). Measuring time: day 3, day 7, 1 month, 3 months. Attitude toward the drug (No change, dose modification, temporary interruption, definitive interruption). Measuring time: day 3, day 7, 1 month, 3 months. Consequence (Recovered, improved,persistent, sequelae). Measuring time: day 3, day 7, 1 month, 3 months. Causality (Very probable, probable, posible, not probable, not related, not evaluable). Measuring time: day 3, day 7, 1 month, 3 months. Treatment (any treatment received during the study different to the intervention drugs). Measuring time: day 3, day 7, 1 month, 3 months. Blood pressure (mm Hg). Measuring time: every 4 hours during the first 3 days and every 8 hours until discharge. Temperature (centigrades degrees). Measuring time: every 4 hours during the first 3 days and every 8 hours until discharge. Glicaemia (mmol/L). Measuring time: at admittance and daily until the 5th day. Hemoglobin (g/L). Measuring time: at admittance and daily until the 5th day. Hematocrit (cu). Measuring time: at admittance and daily until the 5th day. Leukocites count (10 9/L). Measuring time: at admittance and daily until the 5th day. Uric acid (mmol/L). Measuring time: at admittance and daily until the 5th day. Creatinin (µmol/L). Measuring time: at admittance and daily until the 5th day. Potassium (µmol/L). Measuring time: at admittance and daily until the 5th day. Sodium (µmol/L). Measuring time: at admittance and daily until the 5th day. Platelets count (10 9/L). Measuring time: at admittance and daily until the 5th day. Prothrombin partial time (sec). Measuring time: at admittance and daily until the 5th day. Thrombine time (sec). Measuring time: at admittance and daily until the 5th day.
Key secondary outcomes:
National Institute of Health Stroke Scale (NIHSS). Measuring time: at admittance, 3 and 7 days, 1 month and 3 months. Daily life activities (Barthel Index). Measuring time: 7days, 1 and 3 months.