"THE HEART OF THE MATTER"
a special program of the National Emergency Medicine Association (NEMA)


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Week: 600.7 (reprise of 580.7) 

Guest: J. Stanley Smith, Chief of Trauma Svcs, Penn State Hershey Trauma Ctr. 

Topic: New blood supplement will save lives 

Host/Producer: Steve Girard  

NEMA: Most people aren’t familiar with the concept of blood supplements, but they are very important to those of us who are injured in auto accidents or victims of violent crime. A new product is being tested around the country which seems to be far beyond blood supplements we’vehad...and here to talk with us about it today is the Chief of Trauma Services at Penn State’s Hershey Medical Center, Dr. J. Stanley Smith... 

SMITH: There’s been an attempt over the past twenty years ever since Vietnam war to try to replace in some way the use of whole blood or at least blood that has to be donated by people, so that in the military setting that there is an ability to be able to store things and not have to worry about the dating and the storage and some of the other problems you have just with the stored blood itself. So there’s been an ongoing research effort ever since that time to develop essentially an artificial blood. Well, there hasn’t been any real artificial blood that has come along. There are a number of different solutions that have come out of this research effort and they go into two main categories. The first is a, hemoglobin type solution and the second is a proflourocarbon. The object of both of these solutions is they’re looking for a chemical that will carry oxygen like blood does. And the perflourocarbons and so on have not really worked to replace the blood. The hemoglobin solutions have been a little bit better, but even they cannot replace blood completely...so it still remains as a blood supplement, not a blood replacement or blood substitute.  

NEMA: People in a trauma situation are in a bad way...tell me how such a blood supplement helps them, and doctors... 

SMITH: Yea these people are in dire straits, they’re bleeding, they’re in shock, their blood pressure is low, their heart rates are fast and they have about a 40 % chance of dying. Just from the types of injuries we’re looking at for this type study we need to be able to give them something to replace their blood volume and to be able to restore their blood pressure and this offers us an opportunity to do that. Currently what we’re using is a saltwater type solution. Unfortunately we have to give back three times as much of the saltwater as the blood the person has lost. So this amounts to a tremendous amount of fluid. We’re looking for a solution that can have the same properties as restoring the blood pressure and restoring the blood volume without having to give so much fluid back. Obviously the only thing to really replace blood is blood, and we try not to over-utilize blood and on the other hand we try not to under-utilize blood because its a fairly scarce resource right now. So that we’re looking for something that can help us preserve blood supplies in these situations where people need many units of blood replaced, and at the same time be able to give enough blood that we can get these people to survive. 

NEMA: You mentioned using a saline solution. What happens to it once it gets in the blood? People may not understand the process. What happens to the saline? Where does it go? And you mentioned about producing a lot of fluid...I mean where does that go in the body and how is that handled? 

SMITH: When a person goes into shock from hemorrhage, the lack of volume in the vascular system in the blood vessels themselves lets the blood vessels actually become leaky, so that they leak the fluid into the tissues. That’s why we have to give so much fluid back to replace the blood that’s lost and the blood, when we give blood back, it doesn’t leak unless there’s a place where somebodys’ bleeding. But the saltwater solution is unable to stay in the blood vessels like the blood is and so that’s why we have to give so much of it back. This solution also would stay in the blood stream the same as regular blood. It doesn’t leak like the saltwater solution and therefore we don’t have to give as much of it because its not going to leak out into the other tissues. 

NEMA: The new supplement, hemassist...you mentioned one of the properties of it just now...but what overall makes it so much better as a tool to save lives? 

SMITH: This is made from essentially outdated blood. Blood that has been donated by people and which has run the time limit, as far as storage... and then the blood cells in that blood are chemically dissolved and the hemoglobin which is the protein that carries oxygen is purified out and the whole solution is pasteurized to get rid of infectious material and viruses and so on . And then the hemoglobin is cross linked to make it safe so that it’s non-toxic and then it’s suspended back into a saltwater type solution or base that can carry it. This has a property, number one, of carrying oxygen which is important...to get oxygen to the peripheral tissues of the cells...and it also seems to work on its own to help increase blood pressure more so than just giving the volume back. So it has an ability in its own right to increase blood pressure.  

NEMA: Now the release that I got from your center it talks about the availability of this product in conjunction with the FDA allowing emergency situation consent for the use of this product to save lives. What kind of difference does that make where you are? 

SMITH: Generally when you’re doing a study you have to have patient consent before you administer any sort of experimental drug or investigational drug. In a situation of trauma, where somebody is bleeding massively there are quite a number of things that happen. Test procedures, maybe even surgery, that happen in an emergency situation, that may occur without necessarily the patients consent. Not because we don’t want to get consent from the patient, but because the patient is really unable to give consent, and there isn’t any family that we know of that’s close by so that we can ask for consent at the time. Certainly, if the patient is awake in some instances or there is a family member, somebody that we can ask for consent, we certainly always do that. But sometimes we have to do what’s best for the patient in our best medical judgment. In this situation where we’re doing all those things anyway, we’re trying to do what’s best for the patient, but we’re also trying to help the overall problem that’s associated with this type of trauma in the sense that it does have a very high mortality rate. It is essentially a life threatening situation and we’re trying to develop a product to affect that death rate, so that we can get more people to survive and we can get a chance to stop the bleeding.

Therefore the need for this product is fairly immediate... it’s got to be within the first hour of the patients arrival at the hospital. And again often times we may not be able to get consent from the patient because the patient may already be comatose or may not be able to get consent from the family either because we don’t know who the patient is because we don’t get any identification with them, or we haven’t been able to get in touch with the family by the end of that hour. And if we’re going to have any benefit from this, it’s got to be given immediately and quickly or otherwise we won’t have any benefits. So, in order to achieve that the FDA has allowed this ‘waiver of consent’ provision for substances used in emergency research. And this could apply to cardiac arrest or severe head injury or in this instance to hemorrhage. And by going through a very defined process of informing the public, the study is going to be going on...and by asking for reaction from the public to the study before it starts, and by following very strict guidelines, we can then use this in an emergency situation. We would still always try to get consent if at all possible and even if it is used in instances without consent we would approach the family or the patient depending and then inform them that this was used and seek their consent to continue through the remainder of the study. And once the product is given, the remainder of the study mainly has to do with checking blood tests to monitor how the product has been metabolized, checking on the patients progress to make sure that they survive. 

NEMA: Now the nurse who is the head of clinical research and surgery section mentioned a number that she was hoping that the number of fatalities might be brought down by. Is that something that you are in line with? Is there a certain goal? 

SMITH: The goal is that we could decrease the mortality rate by twenty-five percent which would, since these are very, very severely injured patients, would take the current death rate of forty percent and hopefully cut it back to thirty percent, so that would be that twenty-five percent decrease. 

NEMA: That is very important and this does seem like a very important advance then to me. I mean it gives you that, I’ve talked with people in trauma centers here and in their early heart attack care and CPR rooms and they said that first hour, that first hour is so important. 

SMITH: The first hour we call the golden hour and it’s really the most important for the overall care of the patient. Many of the things that happen within that hour are going to determine the overall outcome for the patient. 

NEMA: Dr. J. Stanley Smith, Chief of Trauma Services at Penn State’s Hershey Medical Center. The study is expected to run about a year at 40 trauma centers, and Hemassist comes from Baxter Health Care in Chicago. 

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NEMA: Thanks for joining us for today’s program. If you have any comments or suggestions, contact this station. Or visit our home page at: www.nemahealth.org/ ...for a look at transcripts of this or past programs, or to find out more about the National Emergency Medicine Association. I’m Steve Girard at The Heart of the Matter.