This trial is in addition to two other recently-announced non-US trials of the product, in ischemia applications, that have received regulatory clearance to proceed.
The UK Medicines and Healthcare products Regulatory Authority (MHRA) approved the protocol for a non-randomized, multi-center, prospective registry of patients undergoing multi-vessel coronary artery bypass graft (CABG) surgery. The trial is designed to assess the product’s safety and feasibility in reducing heart damage, as measured by cardiac enzyme (CK-MB) elevation, and enhancing tissue preservation during cardiopulmonary bypass.
Secondary endpoints include measurements of major adverse cardiac events, kidney function, transfusion requirements, cognitive impairment and length of hospital stay.
In the trial, a total of 60 patients will be consecutively enrolled in two groups to receive either standard-of-care treatment or intravenous administration of Hemopure (hemoglobin glutamer – 250 (bovine)) prior to cardiopulmonary bypass. Patients will be monitored until hospital discharge or six days, whichever occurs first, with a follow-up assessment at 30 days post-surgery. An independent data safety monitoring committee will monitor safety throughout the study period.