New Blood.... (Updated & Bumped)
This is a reminder to all Houston residents. You may find yourself the subject of a medical experiment without your consent. Sounds bad doesn't it? Well, maybe not. You see, there is a company that is conducting a Phase III trial of a synthetic blood substitute here in cooperation with over 18 sites around the country including Hermann Hospital's Life Flight. If Life Flight responds to an emergency where the victim has suffered massive blood loss, and has no contraindications for it's use (pregnant or may be so, massive head trauma, or any other injury that is not likely to allow the patient to survive), that patient may, by random lot, be given a product called PolyHeme. This product, made by Northfield Labs, is made from expired human blood. The red cells are separated out, chemically broken open and the hemoglobin is separated from the rest of the cellular material. The hemoglobin is then polymerized. This is a crucial step. Hemoglobin is a very small molecule, so small that it can leak through capillary walls and damage organs. But by polymerizing it, Northfield has found a way to link multiple hemoglobin "tetramers" into long chains which will not leak through capillary walls.
Conventional therapy for blood loss at an accident scene is to supply saline to attempt to dilute the remaining blood in the system. Saline can only do so much however, it cannot carry oxygen itself, if the remaining blood volume is too low, the diluted blood cannot carry enough oxygen to keep the brain and vital organs alive. In Phase I and II trials of PolyHeme some patients have had over twice thier blood volume replaced with PolyHeme with no adverse effects. This product has a shelf life of a full year, this after already expiring as whole blood. This product has no blood antigens in it, so it is universal and requires no typing. This product has been approved by the Jehova's Witnesses as suitable for use. As I type, over 250 patients have recieved this product at the scene of an accident and the goal of the trial is 750 patients. This trial is possble because the FDA has a stipulation that if sufficient local notification is made, and the patient is in serious risk of dying without the experimental treatment, the patient can be enrolled without providing informed consent.
Full disclosure: I own stock (admittedly less than I'd like to own, but my investment money is limited.) in this company. I do so because I believe this is a revolutionary product that can save thousands of lives a year. If you'd like to learn more you can go to Northfield Labs Website
UPDATE: 11/28/05
Northfield labs has announced the results of the fourth (and I believe final) interim review of the Phase III study with positive results. The independent review committee looked at the outcomes of the first 500 patients and concluded that no modification to the study needs to be made and the study can continue without interruption. A new day in acute trauma care steadily marches closer.
Conventional therapy for blood loss at an accident scene is to supply saline to attempt to dilute the remaining blood in the system. Saline can only do so much however, it cannot carry oxygen itself, if the remaining blood volume is too low, the diluted blood cannot carry enough oxygen to keep the brain and vital organs alive. In Phase I and II trials of PolyHeme some patients have had over twice thier blood volume replaced with PolyHeme with no adverse effects. This product has a shelf life of a full year, this after already expiring as whole blood. This product has no blood antigens in it, so it is universal and requires no typing. This product has been approved by the Jehova's Witnesses as suitable for use. As I type, over 250 patients have recieved this product at the scene of an accident and the goal of the trial is 750 patients. This trial is possble because the FDA has a stipulation that if sufficient local notification is made, and the patient is in serious risk of dying without the experimental treatment, the patient can be enrolled without providing informed consent.
Full disclosure: I own stock (admittedly less than I'd like to own, but my investment money is limited.) in this company. I do so because I believe this is a revolutionary product that can save thousands of lives a year. If you'd like to learn more you can go to Northfield Labs Website
UPDATE: 11/28/05
Northfield labs has announced the results of the fourth (and I believe final) interim review of the Phase III study with positive results. The independent review committee looked at the outcomes of the first 500 patients and concluded that no modification to the study needs to be made and the study can continue without interruption. A new day in acute trauma care steadily marches closer.
posted by Rorschach at
11/28/2005 04:08:00 PM
9 Comments:
Rorschack,
Have you, or anyone else in your family, been transfused with this synthetic blood?
Sherri
Nope, Thankfully nobody I know has had the misfortune of needing a transfusion of any type. What I find most interesting about this product is the fact it can be administered AT THE SCENE. Since typing is not an issue, there is no worry about blood type matching. I'm still researching it myself but I have read that the DOD supplied a large chunk of research money through DARPA for the early development. Makes sense. I have surmised, but I'm not sure, that the product can be freeze dried and rehydrated at the scene. I could see where the DOD would LOVE to put this stuff in an army medic's bag. Or even better in every soldiers pack. Given the small single use water filters that are available, I can envision a medic scooping up a bucket of muddy swamp water, pumping it through one of these filters, using this filtered water to rehydrate the blood substitute and saving a fellow soldiers life in the middle of some battlefield somewhere. Gives the whole "golden hour" concept a new twist.
The reason why I posted about it is that the study is half finished and I haven't seen a peep about it anywhere except the Chronicle and then only right before the study started back on February 12, 2004. It seems reasonable that people might want to know about this. And I'm sure not everybody saw the original article over a year ago.
OMGosh! Swamp water to synthetic freeze-dried blood! I suppose if my life depended on it, AND it had been thoroughly tested, I'd get over it, but ewww! LOL But I can see why DARPA would be interested in it. I've read some of their other interests that were much creepier from defense newsfeeds.
If they find no future complications from their tests, I think synthetic blood would be good for ambulances since fresh blood (unfrozen) only lasts for two hours, and carries serious risks from mis-typing. I don't recall any of our patients that recieved blood expanders having serious complications from it (one brand did give bad diarrhea).
I read something about synthetic blood being tested in another city, maybe about 6-12 months ago. But not much since, and I subscribe to quite a few medical/science newfeeds (but when I get behind online, I mark many feeds as read even though I didn't glance through them, so I could have missed a more recent article).
well, I can see where it might gross you out, but there are reverse osmosis filters that can filter out stuff as small as viruses, (prions? dunno) so risk of infection should be non-existant. and if its a question of keeping the guy alive or not, hey, they can always administer antibiotics back at the batallion aid station.
Just had a look over the Northfield site, there have been over 400 patients enrolled as of the first week in July. Northfield expects the number to be at or around 600 by year end. They expect to issue a progress report based on the last interim look before the study ends before the end of the year. The study is expected to end in the first quarter of 2006 if not sooner at current enrollment rates.
That is a product with tremedous potential. Aside from being used by ambulance crews, it will be helpful in the ER.
In Europe (and I suspect the US) most volume expanders (which seems to be the main use for the product) are either colliods or crystalliods rather than saline solutions. Do you hace any idea of how it is expected to compare in cost to other volume expanders?
Too high a cost may limit it to only the worst sorts of trauma.
In any case, please keep posting on this topic. My wife is an anesthesiologist (in much of Europe they staff ambulances) and had never heard of the trials. She is quite interested.
Also, JWs are more frequently showing up in the ORs here in Bern. Such a product could help eliminate blood loss risks.
I do not expect cost to be a huge driver in this products acceptance. I'm sure there will be some volunteer ambulance services that cannot afford to put in thier ambulances, but those operated by the county/city probably will. Northfield has not made public it's marketing plans so nobody knows what it is going to cost per unit. I would expect few people will complain about the bill if it keeps them alive.
DSB, thanks for stopping by! I was unaware that Northfield had publically disclosed any marketing plans. Your price of a grand per unit does at first blush stagger you a bit, but your reasoning for it saving money seems sound. That said, your argument that insurance companies will look far enough ahead to see that it will save money in the long run may or may not be valid.
Medical insurance companies tend to think in terms of quarters, or a year at most. They don't look at 5, 10, or 20 year time spans. The reason is that most people who are severly injured cannot work and many don't have long term disability insurance and therefore they blow through thier savings quickly and cannot keep up the insurance payments and thier insurance is dropped. They end up on the public dole for long term care. For years, medicare would pay for surgery, but wouldn't pay for care that would prevent surgery. This is of course a result of political choices made by people who have no grasp of medicine or the insurance industry. (these are the same sorts of decisions that have left us with only two vendors for injectable flu vaccine and a third nasal vaccine that nobody including private insurance will pay for ) These will be the same sort of people who make similar decisions about outfitting private, volunteer, city and county ambulances with polyheme. I'm not particularly encouraged by that thought.
Just take a look at the quality of care you get in any British or Canadian hospital and you'll see what I mean. If an American hospital treated thier patients that way they'd be sued into oblivion by the widows and widowers. But there everyone just shrugs, lights up another cigarette, and says, well, my doctors visits are free, why should I worry about cancer? Without realizing that in the states, if they get cancer, they might have a decent chance at surviving whereas in Canada, they are basically pumped full of moriphine and allowed to die of it because the cost of all but the most inexpensive chemo and radiation is too high. You get the care you pay for.
Is there any other companies making a smiliar product to PolyHeme?
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