Diagnosing Deadly Blood Clots?
ORLANDO, Fla. (Ivanhoe Newswire) - More people die from preventable blood clots than from breast cancer, AIDS, and traffic accidents combined. And chances are you're at risk since about 900,000 people get them every year in the U.S. Researchers are now taking new measures to evaluate your risk of developing potentially deadly blood clots.
The Flecks love Disney, but this isn't a vacation. They're in a waiting area of the hospital where Jason experienced some of his darkest days. It's where he was treated for potentially deadly blood clotting and cancer.
"I also had non-Hodgkin's lymphoma as well. One of the nurses had said to me, had I not come in when I did, I may not have made it another day," Jason Flecks, told Ivanhoe.
Jason stumbled onto the bad news when he fell off a trampoline at a kid's birthday party.
"I went to see an orthopedic doctor who said there's nothing wrong with your leg, but you may have blood clotting," said Flecks.
"It's the number one reason why you might die in a hospital," Florida Hospital Doctor John Francis, told Ivanhoe.
And not even know you were in danger. Researchers are working on a new test to solve that mystery. It offers a full picture of how your blood cells and proteins work together to form a clot.
"We're measuring the production in the blood of an enzyme called Thrombin. It's really the key—too little, you bleed, too much, you clot," explained Doctor Francis.
The goal is to eliminate preventable complications, so at-risk patients like Jason can plan family vacations for years to come.
Jason didn't know he had the genetic blood clotting disorder until the trampoline accident. So far, knock on wood, his cancer is in remission.
Researchers are hoping to launch clinical trials for the blood clotting diagnostic test by 2014.
BACKGROUND: Blood clots can occur under many different circumstances and in many different locations. Blood clots that form in response to an injury or a cut are beneficial, stopping potentially dangerous bleeding. However, a number of conditions can cause you to develop blood clots in critical locations, such as your lungs and brain, and they require medical attention. (SOURCE: http://www.mayoclinic.com/health/blood-clots)
CAUSES: Factors and conditions that can cause blood clots, as well as serious conditions that are associated with blood clots once they form and travel to other parts of your body, include:
- Antiphospholipid syndrome
- Certain medications, such as oral contraceptives, hormone therapy drugs and some breast cancer medications
- Family history of blood clots
- Prolonged sitting or bed rest
TREATMENT: The thrombin generation assay (TGA) is the only global assay that describes the overall capacity of a patient to generate thrombin. Scientists at the Center for Thrombosis Research have further developed and standardized this sophisticated method through extensive work over the last two years. Our method now represents a fully validated, state-of-the-art way to study procoagulant activity in plasma, cancer cells and suspensions of cellular microparticles. We are also working to validate the thrombin generation assay in whole blood samples, and to establish a method for the measurement of microparticles in the blood of cancer patients. This research will contribute to our understanding of cancer-associated hypercoagulability, and could ultimately provide a critical tool for hematologists and oncologists alike, with distinct ramifications for improved patient care. (SOURCE: www.fhthrombosis.com/CurrentProjects)
John Francis, Ph.D., Director of the Florida Hospital Center for Thrombosis Research, talks about a new method for diagnosing blood clots.
Can tell me a little bit about the diagnostic test you created?
Dr. Francis: Well first of all, let me set the scene by saying that thrombosis or blood clots are the number one cause of death in the United States. Many heart attacks are blood clots; 80% of strokes are blood clots; it could the first sign of a developing cancer; it is a common cause of death in cancer; and it could be a complication of cancer treatment. Overall, it is a very important problem in the medical field. Now, we have a lot of diagnostic tests to determine whether someone is likely to bleed; for example, after a surgery, but we don't have a very good way to predict who is likely to develop a blood clot. We have many tests that can measure little pieces of the blood clotting system; it is a very complicated system in the blood; dozens of different proteins interact to cause a blood clot or prevent a blood clot. And we can measure all of these different little pieces, but that is kind of like taking a snapshot in time. It does not really tell us anything about the risk of an individual patient developing a blood clot and that is really why we have attempted to look at the whole blood clotting system in a different way and develop this test.
So you can look at now all of it at once?
Dr. Francis: Correct, we are actually looking at all of the blood clotting system at once, and more importantly, we are looking at it in whole blood. Conventionally, most coagulation laboratories like ours even, that measure different pieces of the blood clotting system, do so in blood plasma. In other words, we separate the red blood cells from the plasma and we test the plasma. But that is not how our blood flows around our body. Looking at it in whole blood is a more physiological way, in other words, nearer the situation that exists in an individual patient and I think it is going to give us, in the long run, better results.
If I may I ask, why hasn't this been done before? It seems so logical.
Dr. Francis: You are absolutely right. It is a very logical way to do it and people have tried to do it before, but there has been some technical problems with doing it and one of the things that we manage to do in our laboratory is overcome those technical limitations and we have been able to get a US patent on the technology that we have developed because of that.
In the most layman's terms, what is it that makes your test successful versus the ones that have not been successful in the past?
Dr. Francis: What we are doing is we are measuring the production in the blood of an enzyme called thrombin. Thrombin is really the end result of the whole blood clotting system. Many clotting proteins interact with one another in a complicated way, but the net result is the production of this enzyme called thrombin. Now, why that is important is if you make too much thrombin, you are likely to cause a blood clot. If you do not make enough thrombin, you are more likely to bleed. So, what this test does is measure the generation of this enzyme thrombin in whole blood using some fluorescent technology and that has overcome some of the limitations that other investigators and researchers in the past have run up against.
Who would this test be appropriate for?
Dr. Francis: Really any patient that is at risk of a blood clot. This includes, for example, many cancer patients. Most types of cancer increase the risk of a blood clot. So any cancer patient undergoing treatment, for example, particularly cancers like pancreatic, lung, brain; those kinds of cancers are much more likely to produce blood clots. These patients would probably benefit from the new test particularly while they are undergoing treatment Cancer treatment itself increases the risk of having a blood clot and it would be extremely useful to be able to predict, which patients are more likely to be at greater risk of having a blood clot so that we can intervene, possibly with some anti-clotting treatment to prevent that from happening. Also, any patients that have a family history of a blood clot could benefit from a test like this.
Is there any proof of performance; comparing the results of this diagnostic test versus the current standard?
Dr. Francis: That is a great question and that is exactly where we are going with this test right now. Before we can really use it in the ways that we hope to use it, and the ways that I have described, we have to do those exact trials that you have described. We have to compare it to some of the tests that we can do now to see if it gives us some added value and that is exactly where our clinical trials will take us over the next couple of years.
Do you have any details on the clinical trial, like when it is starting or how many patients or anything or is it still too early?
Dr. Francis: It is still a little early for that. We still have to identify the patient populations that will perhaps most benefit from this kind of test and set those up and look for some funding, for those trials, but we anticipate that that should happen in the next 12 to 18 months.
How frustrating is it to get the funding? I know that for researchers, my husband is a scientist, it has always been challenging, but it seems like it is more challenging now, is that the case?
Dr. Francis: Oh certainly, it is much more challenging than it was even five or ten years ago to get funding. It is particularly challenging to get federal funding. Those budgets have constricted dramatically over the last few years. Our laboratory has been very successful in attracting commercial funding from drug companies and from companies that make diagnostic reagents and instrumentation. And quite frankly that is where we are going to look for this kind of funding. We probably won't look to federal sources. We will look to commercial sources to fund this kind of work.
Why is it important to hand the money over for this type of research?
Dr. Francis: Well because we can't realize the benefits that we believe this technology will have until we do the clinical trials and unfortunately any type of clinical trial costs money. So, right now we are in this limbo stage where we are pretty much ready with the technology, but need funding to take the next step. In fact, we have one US patent on the original method, and we have a US patent pending on an enhanced version which is the one that we want to take into clinical trials. However, we certainly do need to get funding to take this to the next level.
Why should people care about this research?
Dr. Francis: That is another great question. When we talk about thrombosis, I suspect the average man on the street has no idea what thrombosis is, but as I said earlier, it is a major cause of death in the western world. It is the number one reason why you might die in a hospital. For example, a pulmonary embolism, a blood clot in the lungs, is not an uncommon occurrence after a major surgery. It is still the number one reason why a woman will die after childbirth even though that is a relatively rare, thank goodness, occurrence. As many as a million people a year develop a pulmonary embolism in this country and up to a quarter of these may prove fatal. Many more get deep vein thrombosis, a potentially debilitating condition which can lead to other problems. So, it is a major medical issue in the United States and other western countries for that matter, and one we need to be concerned about.
This is really going to make a difference in saving lives?
Dr. Francis: I think so because as I said earlier on, the amount of this enzyme, thrombin that gets generated is really the key; too little you bleed, too much you clot. These individual tests which are available, we do them every day; we do thousands of them a year, they are just a snapshot. They don't really tell anything about the risk for an individual patient and that is the difference, I believe, that this test is going to make a difference.
Many people actually get these blood clots every year and they are still called the silent killer, why is that?
Dr. Francis: It is a silent killer because a pulmonary embolism, a blood clot to the lung can kill very quickly. Less than half of the patients who die of this condition are diagnosed with it prior to their death, so it often goes unrecognized. You may get shortness of breath, which may have been preceded by pain in the leg. But sometimes you don't even get any warning like that, the patient just simply slips away, almost like a heart attack; very quick, and very silent. It is an under recognized problem and one we need to pay more attention to.
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