03/14/2006

Blood Substitute Study to Begin

Treatment to Begin at Scene of Injury

MORGANTOWN, W.Va. –Ambulances in three northern West Virginia counties will soon begin carrying an experimental blood substitute.

“Each of the EMS squads serving Monongalia, Marion and Harrison counties will participate in this clinical trial,” said Larry Roberts. M.D., director of the Jon Michael Moore Trauma Center at West Virginia University Hospitals. “They will carry a supply of PolyHeme®, a blood substitute, and use it in treating some critically injured patients who are massively bleeding.” 

In this trial, a trauma patient in shock will receive either PolyHeme® or plain saline water starting at the scene of the injury once the ambulance arrives The study will compare the survival rate of patients receiving PolyHeme® to those of patients who receive only plain saline water, which is the current standard of care.

WVU is one of a number of trauma centers around the U.S. participating in the clinical trial.

 Trauma-related injuries are the leading cause of death among Americans under 45 years old, according to the CDC’s National Center for Injury Prevention and Control.   Almost one in five trauma patients who die from their injuries die as a result of massive bleeding and insufficient hemoglobin to carry oxygen to the brain, heart and other vital organs. 

“If we can rapidly treat some of these severely bleeding patients with a replacement fluid that, like blood, can carry oxygen, we may see more survivors in this young population.” Roberts said.

Severely injured and massively bleeding patients are themselves unable to give consent before treatment with the experimental blood substitute. Dr. Roberts explained that the trial will be therefore conducted under federal regulations that allow for clinical research in emergency settings using an “exception from informed consent.” 

Consent will be obtained at the earliest possibility from the patient or designated family member, and at any time the experimental PolyHeme® can be stopped.

Dr. Roberts has been actively informing the public about PolyHeme® and this trial, well in advance of supplying it to the ambulances. Over the past ten months, he has spoken to community groups, city councils, and has appeared on TV and radio. There have been many newspaper articles and advertisements as well. “We want everyone to be completely informed. We do not want to enroll anyone in the trial who does not want to be considered for the use of PolyHeme,” he said. “Anyone may choose not to be a participant and can obtain and wear a medical alert-like bracelet.”

This bracelet is available from the manufacturer of PolyHeme®, or from the Jon Michael Moore Trauma Center. 

PolyHeme®, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available. It has already been extensively studied in trauma trials in the hospital setting but this study extends the opportunity to treat even earlier (at the scene of the accident and enroute to the hospital,) and maybe improve survival. PolyHeme® is manufactured by Northfield Laboratories Inc., of Evanston, Illinois.

Anyone who would like more information about the trial, or would like to obtain a bracelet to exclude themselves from the study, may contact the Jon Michael Moore Trauma Center at 304-598-4659.

- WVU -


06-057
For more information:
Bill Case, HSC News Service, (304) 293-7087
casew@rcbhsc.wvu.edu
bc:03-14-06

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