Posted on 07/19/2005 5:50:50 PM PDT by SandRat
FORT SAM HOUSTON, Texas, July 19, 2005 – A blood substitute that might save lives on the battlefield will be tested in San Antonio through a research protocol already underway in 22 communities across the nation.
Brooke Army Medical Center and University Hospital are participating in a groundbreaking national clinical trial to evaluate the safety and usefulness of PolyHeme, an oxygen-carrying blood substitute, in increasing survival of critically injured and bleeding patients.
Under the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the air ambulance, and continue during a 12-hour post injury period in the hospital.
Since blood is not presently carried in ambulances, the use of PolyHeme in these settings has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is currently not available.
The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution.
“We are excited to be included in this groundbreaking clinical trial,” said Col. Toney Baskin, an Army trauma surgeon and the principal investigator on the study.
Trauma-related injuries are a leading cause of death among Americans under 45 according to the Centers for Disease Control and Prevention National Center for Injury Prevention and Control, Baskin said.
“Almost one in five trauma patients die from their injuries,” Baskin said. “If we can begin to treat these patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we might well see more survivors.”
Because the patients eligible for this study are unlikely to be able to provide informed consent due to the extent and nature of their injuries, the study will be conducted under
federal regulations allowing for clinical research in emergency settings using an exception from the requirement for informed consent.
Use of this provision in a study protocol is granted by the Institutional Review Board responsible for approval of the research study if the board finds that patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unsatisfactory, potential risks are reasonable, and participation in the study could provide a direct benefit to the patients enrolled.
Baskin said that San Antonio Airlife personnel would use the blood substitute. San Antonio Airlife has a paramedic and a nurse aboard each of their flights bringing trauma patients to facilities like Brooke Army Medical Center.
PolyHeme looks like blood, but only stays in a patient’s system for about 24 hours.
“It can buy you time in a trauma situation,” Baskin said. “But it will not eliminate the need for blood banks.”
He said that current research indicates the product is very safe and that there are no serious adverse events attributable to the use of PolyHeme.
PolyHeme, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available.
PolyHeme has previously been studied in the hospital setting in trauma patients demonstrating an improved survival, according to the Journal of the American College of Surgeons, October 2002.
PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Ill. It requires no cross matching, making it immediately available and compatible with all blood types, and has an extended shelf-life of more than 12 months.
Army medical research
I wonder if it has the same levels of 2-3-DPG as human blood. Though if the standard it is being compared to is that of a crystalloid, I guess that's pretty much a moot point.
Got me! I'll leave that to the FRMedicals to argue.
I'm surprised it took the Army so long to get on board. Thanks for the post.
I am a street medic in KC. I hope it works. The impact would be huge.
Anybody know what the storage limitations of this stuff are? I mean, can we toss it in everybody's rucksack like we do with Ringer's Lactate and then use it for a pt with traumatic blood loss or hemhorrage?
We've had a couple of guys take a lot of Ringers' and just barely make it to the hospital. That's even true in accidents -- we've had bad internal injuries on jumps, and a guy headshot on a training range. But it really would come into its own in the war. We have had guys unable to be medevaced overnight due to weather or aircraft availability. Our Australian counterparts lost a good man due to a femoral artery wound. They were able to pump his volume up but volume alone can't do it if you can't carry enough O2 to vital tissues.
(For the non-medically-aware, Ringers Lactate is a blood expander -- all it does is put some fluid volume in the system to replace lost blood and keep pressure in a survivable range, but unlike human blood, it can't carry oxygen. If fresh oxygen doesn't get to living tissue, the tissue dies -- starting with the patient's central nervous system).
d.o.l.
Criminal Number 18F
I gave you all that I had. Maybe a call to Brooke Army Hosp from your Hospital Drs.?
There are some other advances which have taken place over the last two or three years which are helping many more troops survive.
The public knows about the armor, but there have been a whole bunch of medical advances, from point-of-injury stuff like Curlex, to new advances in emergency medicine, like a lung machine they have in Landstuhl to prevent death from lung burns.
I think (I dunno for sure) that these things started out on the civilian trauma market and then were quickly adopted by the military. The lung machine, for instance, is experimental but it is saving lives.
d.o.l.
Criminal Number 18F
Research into finding safe effective red cell substitutes has been going on for many years, and now is being pursued mainly by biopharmaceutical companies. The two main classes of oxygen-carrying agents are stroma-free hemoglobin solutions and non-hemoglobin solutions, notably perfluorohydrocarbon emulsions. Toxicity of the latter has limited its use to support oxygen delivery during percutaneous coronary angioplasty.
Hemoglobin solutions appear very attractive, offering the advantages of a product devoid of red cell antigens, able to be virally inactivated, stored for long periods of time, and available in the field for use in mass trauma situations. However, because of its high oxygen affinity and rapid renal excretion, it requires chemical modification with crosslinking and polymerizing agents such as pyridoxal phosphate. Toxicity remains a major challenge - risks of bacterial sepsis (due to the the effect of iron on bacterial growth) and vasoconstriction due to binding of nitric oxide by the hemoglobin. A few products have reached the clinical trial stage - the most promising to date being a pyridoxalated polymerized hemoglobin solution ("PolyHeme") developed by Northfield Laboratories in Illinois. If successful, this product, and others likely to follow, may replace red cells for many of the current indications such as acute blood loss.
It might need to to carried in ammo cans or special, hard containers when dismounted. Dollars to donuts, the government will buy special, hard containers if PolyHeme works.
BTTT!!!!!!
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