Blood substitute to be studied in trauma patients

San Antonio (December 18, 2003) — Every second counts for severely injured and bleeding patients. Stabilizing patients suffering from massive blood loss is a top priority and serious concern for emergency responders at the scene of many motor vehicle collisions and other traumatic injuries. It’s called hemorrhagic shock and it’s a problem that can become life-threatening very rapidly. For this reason, The University of Texas Health Science Center at San Antonio (UTHSC), in collaboration with University Hospital, has been chosen to be one of the participating centers for a national study of PolyHeme®, an investigational blood substitute.

Principal Investigator Ronald Stewart, MD, associate professor of surgery at the UTHSC and trauma medical director at University Hospital, and the UTHSC surgical trauma team will study PolyHeme’s ability to increase survival in adult patients suffering from hemorrhagic shock. The purpose of this study is to evaluate the safety and use of PolyHeme in treating patients with hemorrhagic shock.

Hemorrhagic shock causes the patient’s blood pressure to become dangerously low. The lack of blood-carrying oxygen to the body’s organs can cause the organs to have difficulty functioning and potentially stop working.

PolyHeme is an investigational, universally compatible, immediately available oxygen-carrying resuscitative fluid designed to treat hemorrhagic shock where blood transfusion is required but blood is not available.

Treatment would begin by San Antonio AirLife crews, either at the scene of the injury or while in flight to University Hospital, a Level 1 Trauma Center. Treatment would continue through a 12-hour post-injury period in the hospital.

The AirLife patients enrolled in this study will be selected randomly to receive either PolyHeme or the current standard of care (intravenous saline solution). Due to the fact these severely injured patients will be unable to give informed consent prior to enrollment, the study uses a provision for an exception from informed consent requirements in accordance with federal regulations (21 CFR 50.24). Patients, and their legally authorized representatives or family members, will be notified at the earliest opportunity. A patient may withdraw or be withdrawn from the study at any time. If a patient is withdrawn from the study, he will continue to receive treatment for his injuries and the quality of care will not be impacted.

This federal regulation allows the UTHSC Institutional Review Board (IRB) to approve a clinical trial without requiring informed patient consent, provided specific criteria are met. These criteria include:

• Patients must be in a life-threatening situation
• The experimental treatment must offer patients the potential for direct clinical benefit in the form of increased survival
• The risks are reasonable
• Without an exception from informed consent the research could not be conducted

A prerequisite for study approval under these circumstances is public disclosure and community consultation. Community meetings will be held in San Antonio and throughout the 22-county South Texas region that makes up Texas Trauma Area P. Notices will be made of these meetings so all individuals interested in learning more about this study and who wish to offer feedback may do so.

This type of groundbreaking clinical research is vitally important since trauma-related injuries are the leading cause of death among Americans under the age of 45. According to the U.S. Centers for Disease Control and Prevention, more than 2 million people are seriously injured due to trauma in the United States each year.

Additional information is available by writing to the project coordinator at the UTHSC Department of Surgery trauma offices, 7703 Floyd Curl, San Antonio, Texas 78229-3900 or by calling (210) 567-3623.

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