Who will be excluded from the study?
• Women who are obviously pregnant • Patients with severe brain injuries • Patients who require CPR to maintain their heartbeat • Patients with “unsurvivable” injuries • Patients who are known to object to blood transfusions • Patients who are known to refuse resuscitation How many patients will be enrolled in the study? A total of 720 patients will be enrolled in the study; 360 patients in the control group and 360 patients in the PolyHeme® group. Has enrollment begun anywhere? Currently, enrollment is underway at 22 Level I trauma centers across the United States. A list of those centers is available at www.clinicaltrials.gov. The FDA has approved this study as well as a total of 22 Institutional Review Boards. One IRB did not approve the study. How will patient safety be assured in this trial? An Independent Data Monitoring Committee, consisting of independent medical and statistical experts, is responsible for periodically evaluating the safety data from the trial and making recomm
