25 August 2014


Thrombosis under control

Maxim Russo, <url>

Thrombosis – the pathological formation of blood clots in the bloodstream – is a serious threat to human health and even life. In our country, the number of patients with venous thromboembolic complications increases by almost 100 thousand people every year. All these patients need particularly careful monitoring of the state of the coagulation system. At the same time, in many cases, timely diagnosis would prevent thrombotic complications.

Early diagnosis of the risks of thrombosis and bleeding is especially important in the selection of antithrombotic therapy, in the treatment and prevention of cardiovascular diseases, thrombosis after surgery. The most effective for such diagnostics today is the thrombodynamics test. The test is based on long–term studies of the blood coagulation system, which were conducted on the basis of the Hematology Research Center of the Russian Academy of Medical Sciences. The company "GemaKor Labs", a resident of the biomedical technologies cluster of the Skolkovo Foundation, is working on the second generation of the test – "Thrombodynamics-4D". Recently, the foundation's grant committee decided to grant 60 million rubles for its development and clinical testing.

Properties of bloodOne of the properties of our blood is the ability to clot in a timely manner, that is, to form a clot – a blood clot to stop bleeding.

If this mechanism is broken, the folding system does not work correctly. The most famous example for all of us is various types of hemophilia, but doctors are well aware that blood clotting disorders accompany many different diseases and conditions, and can seriously complicate treatment and prognosis.

Blood clotting itself is a very difficult process. Blood contains many different components that interact with each other in a certain way. And in particular, if a blood vessel is damaged, then the contact of blood with protein molecules that are located in the thickness of the wall of this vessel immediately triggers the gradual formation of a blood clot. First, a "plug" of platelets is formed. Further, proteins that are part of the blood plasma enter into this process, and as a result, the platelet plug is "compacted" with a special fibrin gel. This process develops in time and in space as, relatively speaking, a relay race. The relay of blood clotting is closely followed by the relay of stopping this process, as a result, a blood clot of sufficient size appears in the damaged area of the vessel to block the injury site, but not to disrupt blood flow.

Scheme of interaction of blood clotting factors (Panteleev M. et al., Biophys. J., 2010)

However, the saving property of blood can turn into a threat. If for some reason the blood's ability to clot is enhanced, this increases the risk of blood clots. A blood clot can block blood flow, leaving tissues without a normal blood supply. Sometimes blood clots can break away from the vessel wall and enter the bloodstream, posing a threat to vital organs – the heart, lungs. This phenomenon is called an embolism.

A photo of a fibrin clot obtained by scanning electron microscopy.
An increase of 6500 times.

Consequences of thrombosisDisorders of the blood clotting system very often accompany a variety of non-blood-related diseases, or are caused by a whole complex of reasons.

And such clotting disorders are no less, and even more dangerous in their prevalence. First of all, it leads to thrombosis, which is one of the main causes of death in developed countries, in Russia it is about 57% of cases among all causes of death.

Myocardial infarctions, ischemic strokes, pulmonary embolism – all these, as well as many other diseases, result from the fact that a blood clot has formed in some vessel. According to American doctors, pulmonary embolism occurs in 1 person out of 1000 per year – this is a very high indicator. In about half of the cases, the patient dies. In less developed countries, the mortality rate from this disease is even higher. And the older we get, the higher the risk of encountering problems caused by vascular thrombosis.

There are many risk factors that can provoke excessive thrombosis in the blood. These are infections, elevated cholesterol levels in the blood, prolonged inactivity, oncological diseases and hormone therapy. Another risk factor not provided for by nature is surgical interventions and the recovery period after them. And in all these cases, doctors need to find the ideal state of the blood clotting system that will keep the patient healthy.

Therefore, timely assessment of the condition of the coagulation system in the patient is extremely important. It will help, if necessary, to take preventive measures in time, prescribe the appropriate drug. Medications that reduce the activity of the blood coagulation system (anticoagulants) are prescribed to patients who have already suffered, for example, ischemic stroke, myocardial infarction, deep vein thrombosis. But the effect of anticoagulants, including the most modern ones, can have strong individual differences in different patients. And their insufficient or excessive action is dangerous for the patient. Therefore, the effect of the drug must be carefully monitored, and the main tool for this is laboratory diagnostics of coagulation.

Assessment of disorders of the blood coagulation system – thrombodynamics testThere are many laboratory methods for diagnosing the blood clotting system.

However, the vast majority of them are fundamentally outdated. For example, they use too much of the "activating reagent" to start the coagulation, and then the whole system is also mixed. Of course, a small change in the patient's blood, which threatens him with increased thrombosis, is simply lost against the background of such a statement of the study.

A number of tests determine violations only in individual links of the coagulation cascade (remember the first figure) or react to the concentration of the drug prescribed to the patient, but do not reflect the final "total" picture of coagulation. As a result, quite often the doctor finds himself in a situation where the tests contradict the patient's condition. We need a more accurate and more informative way to assess the condition of the patient's blood clotting system. To solve this problem, specialists from the company "GemaKor" have developed equipment on which a new integral hemostasis test is made – a thrombodynamics test. This method is based on studies conducted at the Hematology Research Center of the Russian Academy of Medical Sciences.

In the thrombodynamics test, the clotting process is implemented as close as possible to natural conditions. In fact, we take a blood sample from a patient and place a small amount of blood plasma in a special cuvette. Then we insert a special plate into the cuvette with a locally applied activator simulating a damaged blood vessel wall. That is, we do not add any amount of reagent, but accurately recreate the real picture, almost as in the body. And then, without interfering any more in this process, we simply observe all the stages of the formation of a blood clot in our artificial "damaged vessel". The rate of clot formation and its size are the result of all the accompanying reactions, and there comes a moment when the growth of the clot slows down and finally stops.

Observation and then automatic processing of this process provide information about all the essential characteristics of coagulation: the time of growth delay of the clot, the growth rate of the clot, the presence of spontaneous clots and a number of other parameters. This allows you to simultaneously and independently register clotting disorders at any stage, and gives the doctor a final picture of the patient's clotting condition.

The growth of a clot in a damaged vessel and in a thrombodynamics test.

An important advantage of the method is not only its high sensitivity to disturbances in various phases of coagulation. Individual frames and videos of the growth of the clot very clearly visualize the pathology of the patient.

Photos of fibrin clot in different diagnoses,
obtained by the device "Thrombodynamics Recorder T-2" at the 30th minute of the study.
From left to right: norm, hypocoagulation, hypercoagulation, hypercoagulation with spontaneous clots,
hypercoagulation with spontaneous clots and fibrinolysis.

The data obtained by this method make it possible to diagnose various clotting disorders, carry out personal selection of therapy, including for new anti-thrombotic drugs, and significantly reduce the cost of treatment when using expensive medications (for example, for hemophilia). Due to the high sensitivity to prethrombotic conditions, this method makes it possible to develop a new generation of antithrombotic drugs.

The thrombodynamics test allows you to detect disorders of the blood clotting system, monitor the effect of medications, and check the effectiveness of therapy aimed at both reducing and enhancing clotting.

The device "Thrombodynamics Recorder T-2", on which this test is carried out, has already received certification from the Federal Service for Supervision of Health and Social Development, it is used in medical institutions in Moscow, Yekaterinburg and Novosibirsk. "Registrar of thrombodynamics" is also entering the international market. The first devices were purchased in the UK, Holland, Germany, and are also already used in research laboratories in the USA, France, Sweden.

Now the specialists of GEMAKOR's subsidiary, GemaKor Labs, are working on the creation of the next generation of the device, which is called "Thrombodynamics–4D" and records not only the plasma, but also the thrombin link of coagulation, says the representative of the company Tatiana Fedulova. Such a device has no close analogues on the world market. The domestic device being created within the framework of the project will be an alternative to imported devices currently used in clinics for the diagnosis of clotting (such as thromboelastography, thrombin generation test and others). An important advantage of this research is its speed. If the necessary equipment is available, the test can be carried out, for example, in an ambulance or operating room. It is assumed that the development and clinical trials of the second-generation device will be completed by GemaCor Labs in 2016.


Ruslan Altaev, Head of the Medical Devices and Equipment, IT in Healthcare, cluster of biomedical Technologies of the Skolkovo Foundation, commented on the development of GemaCor:

– With the help of the Skolkovo Foundation, the company is developing the second generation of Thrombodynamics. The new device also provides information about the platelet link of hemostasis, and in addition, the time for conducting the study will be reduced to 15 minutes, which is very important when a doctor needs to assess the situation and make a decision quickly – for example, for resuscitation or an operating room. This will expand the clinical use of the device and give important new information to the doctor for making a therapeutic decision.

Also, the absolute advantages of the new method "Thrombodynamics-4D" should include the ability to evaluate the effectiveness of anticoagulant therapy drugs of the latest generation, which have only recently appeared on the market. This will allow the doctor to predict in advance, even before the appointment, whether a particular medicine will be effective, without wasting precious time and money on ineffective therapy.

In fact, the company "GemaKor" revives the production of medical equipment in Russia, and does it on a global level. Being well aware of the uniqueness of the scientific idea, the company attracts leading European specialists to solve some technical problems. When developing an industrial version of the device, the main task is to achieve the stability and quality of the equipment.

Portal "Eternal youth" http://vechnayamolodost.ru25.08.2014

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