Patient enrollment is complete in our pivotal Phase III study designed to evaluate the safety and efficacy of PolyHeme® when used to treat patients in hemorrhagic shock following traumatic injuries.

This was the first U.S. trial of a hemoglobin-based oxygen-carrying resuscitative fluid in which treatment began in the prehospital setting. Thirty-two Level 1 trauma centers throughout the U.S participated in the trial. Enrollment in the trial was 720 patients.

Treatment began at the scene of injury, continued in the ambulance during transport, and for up to 12 hours post-injury or 6 units in the hospital. The trial is designed to evaluate PolyHeme® compared to the current standard of care, namely salt water in the ambulance followed in the hospital by donated blood, when needed. The primary endpoint is survival at 30 days.

For the sites that participated in the study, click on the link below to be redirected to the NIH’s clinical trial site.

www.clinicaltrials.gov

The trial was conducted using an exception from the requirement for informed consent requirements under 21 CFR. 50.24.

This provision is granted when patients are in a life-threatening situation requiring emergency medical intervention, available treatments are unsatisfactory, previous studies demonstrate the potential to provide a direct benefit (in the form of increased survival) to enrolled patients, the risks are reasonable in relation to what is known about the patients’ medical condition, the risks and benefits of standard therapy, and the risks and benefits of the proposed intervention. It is expected that patients enrolled in this trial will be unable to provide informed consent because the nature and extent of their injuries.

For more information about 21 CFR 50.24, click on the link below to be redirected to the FDA’s website.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm