Oxygen Biotherapeutics, Inc. announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, "Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS).

The trial is a double blind, randomized, placebo controlled study seeking to enroll 760 patients. The number of patients to be enrolled in the trial is an estimate. This is an event driven trial, and will be stopped when the event rate reaches that identified in the study power calculations.

Thus, the number of patients could be less than 760 or higher if the event rate is higher or lower than expected. The protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate.