Check out http://www.northfieldlabs.com/default.htm. You can call them, too. The phone number is online.

My hospital used it once: we had to go through Institutional Review Board protocol for emergency/compassionate use. In order to use it again, we would have to set up a strictly structured research study approved by the IRB.

__________________
Robin Atkins, Coordinator
Bloodless Medicine and Surgery
Tampa General Hospital
Tampa, FL 33606
(866) 662-5333

I attended a meeting at Loyola Medical Center in Chicago IL
regarding Polyheme. I have written a report which will be on this site
tomorrow. In the meantime as stated above you can get information on
the product at www.northfieldlabs.com

__________________
Jan Graziani - LVN
Chicago, IL USA

This information was but forth in EMS magazine February 2004 issue “Blood on Tap History in the Making� Page 41 – Very interesting article on Polyheme, Oxygent and Hemopure.
Polyheme/Northfield Laboratories
Content: Crosslinked glutaraldehyde – polymerized human hemoglobin.
Current Status: Phase III clinical trails in prehospital trauma applications.
Positives: Universal compatibility. Strong early clinical data in traumatic etiologies. High level of purity. Prolonged shelf life.
Negatives: Blood typing post-administration difficult. Dependent on donor blood supply. Possible disease transmission.* Possible immune reaction.**
Interesting Fact: Physicians have replaced up to 200 % of a patient’s total blood volume with Polyheme without complication.

Loyola Medical Center has made public their participation in a national clinical study. The purpose of the study is to evaluate the safety and efficacy of PolyHeme®, an investigational oxygen-carrying blood substitute used to increase survival of critically injured and bleeding patients.

Hemorrhagic shock is the leading cause of death among Americans under the age of 45. Because ambulances and aero medical units do not normally carry blood, the current standard treatment of care is saline solution.

The study by Loyola University Health System will only include six communities in the immediate area of Loyola Medical Center and the responses by LIFESTAR (Loyola’s aero-medical unit.)

Only trauma patients who are in hemorrhagic shock will be candidates for administration of PolyHeme® in the field. (Hemorrhagic means patients who have experienced massive blood loss and shock is a life threatening condition that might include: dangerously low blood pressure, internal organs don’t receive enough oxygen and have difficulty functioning, might lead to death.) Therefore, only those patients who have lost a large amount of blood and are in shock as well as patients who are at least 18 years old and who have sustained severe injuries would be eligible for this study.

This blood substitute will be assigned to patients on a random basis -50% will receive the substitute vs. saline solution. Treatment will begin BEFORE arrival at the hospital and continue 12-hour-post injury. Some of these patients will receive blood after arriving at the hospital, therefore, it is noted that those who refuse blood transfusions for religious reasons would not be eligible to participate in this study. Emergency medical service professionals will know which product to give after opening a sealed envelope in the ambulance.

Excluded from this trial will be:
Patients who are obviously pregnant
Patients with severe brain injuries
Patients who require CPR to maintain their heartbeat
Patients with “un-survivable� injuries
Patients who are know to object to blood transfusions
Patients who are known to refuse resuscitation (DNR)
Patients who are wearing a wrist band that states they do not
wish to participate in this study.
(This wristband is provided to anyone who wishes to wear it
however it would need to be worn at all times)


A discussion of PolyHeme® can be seen at www.northfieldlabs.com

__________________
Jan Graziani - LVN
Chicago, IL USA