Bloodless Coup

There'll be no waivers for patients in this experimental blood-substitute program

The LifeFlight emergency helicopter swoops down to the accident scene. It's bad -- the unconscious victim has lost a lot of blood. An ambulance crew is already there and checking the victim's pulse and blood pressure.

The chopper's blades still whirring, the LifeFlight techs hop out and survey the scene. One of them slips a nondescript envelope out of the emergency kit and rips it open. Inside is a document telling them whether the victim has just been enrolled in an experimental research program. If so, the techs will begin transfusion of an unproven blood substitute, without the victim's knowledge.

The victim, like most Houstonians over 18, has been automatically entered in research conducted by the University of Texas Health Science Center at Houston and Memorial Hermann Hospital's LifeFlight.

Flanagan says the first hour is crucial for trauma 
Memorial Hermann Healthcare System
Flanagan says the first hour is crucial for trauma victims.

The study began last month as part of a nationwide program sponsored by Northfield Laboratories, an Illinois-based drug company seeking approval for its blood substitute, PolyHeme. Northfield trials are already under way in Denver, and the company hopes to conduct trials in 15 or 20 other cities.

Under the informed consent laws, most experimental programs require that participants first be told about the research, and then give written approval before becoming a test subject. For this blood substitute program, the U.S. Food and Drug Administration has issued a waiver so that medical personnel don't need the patients' permission to administer the product to trauma victims. Excluded are patients under 18, pregnant women, the severely brain-injured, those requiring CPR to maintain their heartbeat, those with "unsurvivable injuries" and patients known to object to blood transfusions (e.g., Jehovah's Witnesses) or resuscitation.

Everyone else -- that goes for most readers of this article -- is automatically included. The LifeFlight study aims to administer PolyHeme to 50 patients.

The rare waiver underscores the importance of the research: Companies know that whoever designs the best product will revolutionize emergency medicine -- and make billions of dollars in the process.

Trauma-related injury is a leading cause of death for Americans under 45, according to the UT Health Science Center, which is overseeing the LifeFlight trials.

In these cases, blood is the most critical resource. But donated blood expires after 42 days. Blood cannot be safely transfused at accident scenes and is therefore not usually carried in emergency vehicles, says Tom Flanagan, assistant vice president for emergency services at Memorial Hermann.

Hospitals are required to have O-negative blood, the universal donor, at all times. This is to be administered until the hospital can determine the patient's blood type -- about a 40-minute procedure.

The first 60 minutes following a trauma injury are the most vital -- doctors call it the golden hour. Loss of blood means loss of oxygen to the organs. Between transportation to the hospital and waiting for blood typing, each minute can literally mean life or death.

But even transfusions carry risk -- potentially leading to viral infection and organ failure, Flanagan says.

Seeing the need to find a safe, transportable, universally compatible alternative to donated blood, medical research companies in the 1980s raced to put blood substitutes on the market, ranging from derivatives of cow's blood to completely synthetic fluids.

Blood substitutes are intended to keep patients alive long enough to reach a hospital and gain access to real blood. They are not meant to replace donated blood and, if ultimately approved, could increase the need for donations, says Robin Davidson, public relations manager for the Gulf Coast Regional Blood Center. Davidson, who supports the research, says more trauma patients would reach more hospitals more of the time -- meaning more blood would be needed than ever before.

The companies are expected to conduct stringent clinical trials, on both animals and voluntary human subjects, before seeking FDA permission to waive the informed consent rule. In 1998, Illinois-based Baxter Healthcare Corporation's HemAssist was the first to receive the waiver.

That waiver gave Baxter the lead at the time in cracking what blood substitute companies estimate to be a $5 billion to $10 billion worldwide market. In 2001 alone, American hospitals transfused 14 million pints of whole blood and red blood cells, the National Blood Data Resource Center reports. The volume of transfused blood is increasing 6 percent a year. In Houston, the regional blood center sells red blood cells for $188 per pint, depending on supply and the season; some blood substitute companies projected their prices at up to $1,000 per pint.

Ben Taub General Hospital was to be among 17 hospitals involved in the trials, but before they started at Ben Taub, Baxter ceased testing because the initial results showed a higher-than-anticipated mortality rate. Twenty-four of 52 patients given HemAssist died, compared to eight out of 46 in a control group. HemAssist's death rate was 4 percent higher than Baxter expected. The deaths were believed to be caused by blood vessel constriction.

Then Northfield Laboratories became the front-runner when it received federal research approval for PolyHeme. Northfield CEO Dr. Steven Gould says Memorial Hermann was selected to be in those trials because it's a level-one trauma center that has the necessary resources for proper testing.

But the study is actually under the auspices of Dr. Frederick Moore, general surgery director at the UT Health Science Center.

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