Committee says Biopure trial to continue

The Data and Safety Monitoring Board (DSMB) reviewed mortality and other safety data from the first 21 patients enrolled in the trial at Johannesburg Hospital Trauma Unit in South Africa.

The phase II trial is designed to assess the safety and tolerability of Hemopure, in a hospital setting, for emergency treatment of unstable patients who have significant blood loss as a result of blunt or penetrating trauma.

Patients are randomly assigned to receive either standard therapy resuscitation fluids or up to 10 units of Hemopure plus standard therapy. The treatment period for administering Hemopure is up to four hours from the first infusion.

The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues that would warrant modification of the protocol or early termination of the study. After the trial is completed, the DSMB will meet again to review the data for all enrolled patients and assess the safety of the product.