Innovative Solutions to Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
Phase: NA
Conditions: Acute Respiratory Distress Syndrome, Septic Shock, Sepsis
Sponsor: National Research Center for Cardiac Surgery, Kazakhstan

1 
 
Title: Innovative solutions to 
organ-substituting technologies 
in the treatment of heart and 
pulmonary failure 
 
 
NCT number: Will be provided  
 
 
Date: 15.04.2021 
 
 
 
 

2 
 
1. Abstract  
In order to improve the results of ECMO and septic patients, various techniques used to 
reduce the systemic inflammatory response syndrome, immunocorrection, and others. Today, 
there are many ways to prevent the development of a systemic inflammatory response by 
removing leukocytes from the bloodstream by inserting a filter with a special screen into the 
perfusion circuit to remove leukocytes and prevent them from entering the systemic circulation. 
The most effective method is the hemoadsorption, intended for additional therapy of 
patients with elevated levels of cytokines in the context of systemic inflammatory response 
syndrome. In-patient with acute respiratory distress syndrome and cardiogenic septic shock on the 
background of extracorporeal membrane oxygenation (ECMO) and mechanical support of the left 
ventricle, additionally installed a system for veno-venous hemofiltration, a system designed to 
eliminate a wide range of inflammatory mediators also various proteins and metabolites. 
New methods developed to restore the function of affected organs after implantation of 
mechanical support devices and patients with sepsis will be a great importance both for Kazakhstan 
and for countries with similar category of patients, which will improve the efficiency of surgical 
treatment and reduce the level of complications and mortality. 
Clinical research data will form the basis of practical protocols for extracorporeal membrane 
oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce 
postoperative complications, improve quality of life and reduce mortality after surgery. 
The goal of the program: Improvement of organ-substituting technologies in the treatment of 
heart and respiratory failure.  
Study Design 
Study Type: Interventional (Clinical Trial) 
Estimated Enrollment: 90 Participants 
Allocation: randomized 
Interventional Model: Parallel assignment 
Masking: None (Open Label) 
The results of a clinical study will improve the effectiveness of surgical treatment and reduce 
the level of complications and mortality, improve the quality of life of patients undergoing cardiac 
surgery. The introduction of a clinical protocol for the use of an extracorporeal adsorbent in this 
category of patients will allow standardizing this technique in the Republic of Kazakhstan. 
The data obtained on the treatment of patients with heart and lung failure and organ 
restoration through the use of innovative technologies will provide the necessary information to 

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improve the quality of tertiary care and the quality of life of patients in Kazakhstan and around the 
world. The developed methods can be used as new standards and recommendations both 
domestically and abroad through successful presentations at various conferences. If there are unique 
developments in the use of an extracorporeal adsorbent, patent applications will be filed. 
In general, the expected effectiveness and efficiency of the proposed project will make a 
significant contribution to the development of transplantation, cardiac surgery and cardiology in 
Kazakhstan. 
2. Explanatory note 
1. General information   
1.1. The title of the scientific and technical program (hereinafter - the program): “Innovative 
solutions to organ-substituting technologies in the treatment of heart and pulmonary failure”. 
1.2. The name of the priority area for the development of science, according to which the 
application is submitted. The Science of Life and health. 
1.3. Name of the specialized scientific field in which the application is submitted, type of 
research. Biotechnologies in medicine: New technologies and biologically active substances for 
solving anti, postnatal development aging, prolonging of human life problems. 
1.4. Estimated project start date and duration. 2021-2023 years. 
1.5 Requested amount of grant funding for the entire duration of the project for 2021 - 2023 – 
63 083 thousand tenge, 2021 – 18 574 thousand tenge, 2022- 22 228  thousand tenge,  2023 – 22 
280 thousand tenge. 
1.6. Keywords that characterize the industry and the direction of the application for the 
selection of experts. Organ-substituting technologies. Heart failure. Pulmonary failure. Sepsis. 
Extracorporeal membrane oxygenation. Adsorber 
2. General project concept 
2.1. Introduction 
Principal Investigator – Timur Lesbekov, MD, Chief of Cardiac Surgery Department of JSC 
“National Research Center for Cardiac Surgery” (hereinafter referred to as JSC NNCS). 
JSC “National Research Center for Cardiac Surgery” is a research center that implements a 
program for treating patients with chronic heart failure (CHF) and pulmonary failure (PF) at the 
terminal stage, including orthotopic transplantation of the heart and lungs, mechanical support of 
the blood circulation. 

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The implementation of this project will improve the effectiveness of surgical treatment and 
reduce the level of complications and mortality among patients with heart failure and heart failure 
in the terminal stage. 
2.2. The goal of the program. 
Improvement of organ-substituting technologies in the treatment of heart and respiratory 
failure.  
2.3. Objectives of the program.  
Objective 1. To study the restoration of organ function during implantation of 
extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or 
respiratory failure. 
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal 
hemocorrection procedure. 
Subtask 1.2. Evaluation of the normalization of the organism immune response and 
restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber. 
Subtask 1.3. Evaluation of the normalization of the organism immune response and 
restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion 
cartridge. 
Objective 2. To study the results of applying organ-substituting technologies in the 
treatment of sepsis. 
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal 
hemocorrection in septic patients. 
Subtask 2.2. Evaluation of the normalization of the organism immune response and 
restoration of organ function when using the extracorporeal cytokine adsorber in septic patients. 
Subtask 2.3. Evaluation of the normalization of the organism immune response and 
restoration of organ function when using the extracorporeal hemoperfusion cartridge. 
3. Scientific novelty and significance of the program 
According to statistics, CHF is an increasingly widespread condition in most countries of the 
world. In the general population within adults, CHF is revealed annually in 1-2% of the population 
[1]. With increasing age, the incidence of CHF is increasing exponentially. The incidence of CHF 
reveals its multiple increase in each subsequent age group: in 25-34 years old - 0.02 per 1000 
population, in 55-64 - 3.0-4.0 per 1000, 75-84 years - 13.0- 14.0 per 1000 population [2-5]. The 
constant increase in the number of patients with CHF is associated with both an increase in the life 
expectancy of patients and a decrease in mortality among patients with a complicated course of 
acute myocardial infarction, heart defects, etc. The most common causes of CHF are arterial 

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hypertension, coronary heart disease and myocardial infarction. The gold standard for treating 
patients with terminal heart failure, tolerance to drug therapy is heart transplantation. 
In 2012 the JSC “National Research Center for Cardiac Surgery” developed the heart 
transplantation program in Kazakhstan. Considering the geographical features of our country (donor 
hearts are transported from regions remote from the Center> 1000 km.), remote delivery and heart 
preservation has been developed using an organ preservation system. The Center has been 
performed 81 heart transplants for 8 years. The survival rate by 12 months was 80%. According to 
data, for 2018, more than 200 people need heart transplants every year in Kazakhstan. 
The lack of donor organs remains the most important factor hindering the development of 
lung and heart transplants throughout the world and in our country. 
Extracorporeal membrane oxygenation (ECMO) is a procedure for prolonged 
cardiopulmonary bypass and oxygenation of the blood outside the body, used in patients with 
acutely frisky and potentially reversible respiratory and / or heart failure, whose treatment is not 
amenable to the maximum standard therapy. In 2011, the JSC “National Research Center for 
Cardiac Surgery” launched a program to provide ECMO in Kazakhstan, and in 2016 the Center 
entered to the World Register ELSO (Extracorporeal Life Support Organization) [6-14]. 
Sepsis, septic shock and SIRS are life-threatening conditions associated with an overreacting 
immune response. The deregulated response can lead to multiple organ dysfunction [15-21].  
While sepsis and septic shock have an infectious origin, SIRS may also have non-infectious 
triggers such as cardiac surgery using the Cardiopulmonary Bypass (CPB), ex vivo heart/lung 
perfusion device, ECMO, and Mechanical circulatory Support. This is of particular interest for this 
report. SIRS, sepsis and septic shock have a mortality of an estimated 7, 16 and 40% respectively 
[22-30]. The new 2016 Sepsis-3 definition has two grades: sepsis and septic shock [31-34]. The 
previous sepsis definitions published in 1992 emphasized on the role of systemic inflammatory 
response syndrome (SIRS) as a key element of the sepsis definition. 
However, evidence showed that SIRS criteria are non-specific and insensitive as predictor 
for sepsis related mortality, thus are not included in the most recent international sepsis definitions. 
The members of the Sepsis-3 taskforce suggested that sepsis should be considered in the event of an 
infectious process associated with an increase in SOFA score of two points or more. Patients with 
septic shock would be clinically identified by a vasopressor requirement to maintain a mean arterial 
pressure of 65 mmHg or greater, and serum lactate level greater than 2 mmol/l (>18 mg/dl) in the 
absence of hypovolemia. SIRS patients identified by fulfilling two or more of the four SIRS criteria. 
The two main therapeutic priorities include early identification of a potential infectious origin and 
hemodynamic stabilization of the patient. Other than the control of the primary site of infection, 
there is no causal treatment for sepsis, septic shock or SIRS [35-39]. 

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In order to improve the results of ECMO and septic patients, various techniques used to 
reduce the systemic inflammatory response syndrome, immunocorrection, and others. Today, there 
are many ways to prevent the development of a systemic inflammatory response by removing 
leukocytes from the bloodstream by inserting a filter with a special screen into the perfusion circuit 
to remove leukocytes and prevent them from entering the systemic circulation [9]. 
The most effective method is the hemoadsorption, intended for additional therapy of patients 
with elevated levels of cytokines in the context of systemic inflammatory response syndrome. In-
patient with acute respiratory distress syndrome and cardiogenic septic shock on the background of 
extracorporeal membrane oxygenation (ECMO) and mechanical support of the left ventricle, 
additionally installed a system for veno-venous hemofiltration, a system designed to eliminate a 
wide range of inflammatory mediators also various proteins and metabolites [40-46]. 
There are some new data showing that the use of extracorporeal cytokine adsorber and 
hemoperfusion cartridge for a long time cardiopulmonary shunting (> 120 minutes) may be useful 
in preventing CVS and reducing cytokine levels in patients undergoing heart surgery [47-53]. 
In this study, will be developed methods to restore the function of affected organs after 
implantation of ECMO and patients with sepsis in combination with extracorporeal hemocorrection, 
which will improve the results of surgical treatment of patients with end-cardiac and respiratory 
failure. 
New methods developed to restore the function of affected organs after implantation of 
mechanical support devices and patients with sepsis will be a great importance both for Kazakhstan 
and for countries with similar category of patients, which will improve the efficiency of surgical 
treatment and reduce the level of complications and mortality. 
Clinical research data will form the basis of practical protocols for extracorporeal membrane 
oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce 
postoperative complications, improve quality of life and reduce mortality after surgery. 
 
4. Research methods and ethical issues 
Patients before implantation of ECMO and/or patients with sepsis will enrolled in the study 
after giving a written, signed informed consent. 
The participants will randomized into 3 groups: 
 Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO – 
subgroup A; septic patients – subgroup B. 
 Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 
patients): patients on ECMO – subgroup C, septic patients – subgroup D. 

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 Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO 
subgroup - E, septic patients - subgroup F.  
The investigators will collect demographic, clinical and laboratory data about patients before, 
during and after the operation 
The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital 
stay, the use of vasopressors and inotropes in the perioperative period and incidence of 
perioperative complications and survival will documented. 
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements 
before, during and after the use of ECMO, patients with sepsis will be determined if the 
investigators find relevant difference between the two groups in clinical variables. 
Study Design 
Study Type: Interventional (Clinical Trial) 
Estimated Enrollment: 90 Participants 
Allocation: randomized 
Interventional Model: Parallel assignment 
Masking: None (Open Label) 
 
Experimental (subgroups) 
Intervention / treatment (device) 
Cytokine adsorber  filter will be installed into 
the (hemodialysis or cardiopulmonary bypass 
(CPB) (15 patients on ECMO)  
Cytokine adsorber is a biocompatible, high 
adsorptive polymer indicated in conditions 
where cytokine levels are extremely elevated. 
Cytokine adsorber  filter will be installed into 
the (hemodialysis or cardiopulmonary bypass 
(CPB) (15 patients with sepsis)  
Cytokine adsorber is a biocompatible, high 
adsorptive polymer indicated in conditions 
where cytokine levels are extremely elevated. 
Extracorporeal hemoperfusion cartridge will be 
installed 
into 
the 
(hemodialysis 
or 
cardiopulmonary bypass (CPB) (15 patients on 
ECMO) 
Extracorporeal hemoperfusion cartridge is a 
biocompatible, 
high 
adsorptive 
polymer 
indicated in conditions where cytokine levels 
are extremely elevated. 
Extracorporeal hemoperfusion cartridge will be 
installed 
into 
the 
(hemodialysis 
or 
cardiopulmonary bypass (CPB) (15 patients 
with sepsis) 
Extracorporeal hemoperfusion cartridge is a 
biocompatible, 
high 
adsorptive 
polymer 
indicated in conditions where cytokine levels 
are extremely elevated. 
Control (subgroups) 
 
No filter will be installed into the ECMO  in  

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this study group (15 patients) 
No filter will be installed into the patient with 
sepsis (15 patients) 
 
 
 
Outcome Measures 
 
Primary Outcome Measures  
 
ECMO patients 
1. Difference of Cytokine response [ Time Frame: 6-24 hours ] 
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) 
before initiation of ECMO, 2 hours after initiation ECMO support, at explantation of ECMO 
support, 6-12-24 hours after explantation of ECMO support. 
Secondary outcomes  
1. Ventilator free days (VFD) [Time Frame: 30 days] 
Ventilator free days (VFD) in the first 30 days after randomization, where invasive 
mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator 
days. VFD=0, if the patient dies in the first 30 days after randomization 
2. 
Time 
to 
extubation 
from 
ventilation 
and 
explantation 
from 
ECMO 
[ Time Frame: 30 days ] 
Time to extubation from ventilation and explantation from ECMO. Death under ventilation 
and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last 
visit for surviving patients under ventilation and/or ECMO. 
3. 
Difference of d-dimers [Time Frame: 24, 48, 72 hours] 
Comparison to enrollment or between 3 groups  at 24, 48, 72 h 
4. 
Difference of Serum lactate [Time Frame: 24, 48, 72 hours] 
Comparison to enrollment or between 3 groups  at 24, 48, 72 h 
5. SOFA-Score [Time Frame: 24, 48, 72 hours] 
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the 
higher values explain higher disease severity) 
6. Serious adverse device effects [Time Frame: 30 days] 
Serious complications or malfunctions related to the CytoSorb device 
7. Adverse event of special interest: air in the ECMO system [Time Frame: 30 days] 

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Unintended air in the ECMO system during operation of the device 
8. Adverse event of special interest: blood-clotting in the ECMO system [Time Frame: 30 
days] 
Unintended blood-clotting in the ECMO system during operation of the device 
9. Adverse event of special interest: bleeding complications [Time Frame: 30 days] 
Major bleeding events 
 
Patient with septic shock 
1. Difference of Cytokine response [ Time Frame: 24-48 hours of septic shock ] 
Cytokine response: Level of procalcitonin, Level of C-reactive protein, Level of interleukin-
1, Level of interleukin-6, Level of interleukin-8, Level of interleukin-10, Level of Tumor Necrosis 
Factor- α at 24, 48 hours. 
Secondary Outcome Measures: 
1. Inflammatory reaction [Time Frame: 6 - 24 hours] 
Level of C reactive protein (CRP), white blood cells and procalcitonin immediately after 
induction of anesthesia, before initiation of adsorber, 2 hours after initiation of adsorber, at 
termination of adsorber, 6-12-24 hours after wean of adsorber. 
2. 
Difference of serum interleukin-6 level [Time Frame: 48, 72 hours] 
Comparison to enrollment or between 3 groups at 48, 72 h 
3. 
Difference of serum interleukin-1β level [Time Frame: 24, 48, 72 hours] 
Comparison to enrollment or between 3 groups at 24, 48, 72 h 
4. 
Difference of serum interleukin-10 level [Time Frame: 24, 48, 72 hours] 
Comparison to enrollment or between 3 groups at 24, 48, 72 h 
5. 
Difference of serum procalcitonin level [Time Frame: 24, 48, 72 hours] 
Comparison to enrollment or between 3 groups at 24, 48, 72 h 
 
Other Pre-specified Outcomes: 
1. •Overall survival time [ Time Frame: 30 days ] 
Overall survival time, defined as time from randomization to death. The time will be 
censored at the time of last visit for surviving patients 
2. •Days on intensive care unit (ICU) [ Time Frame: 30 days ] 
Days on intensive care unit (ICU) 
3. •Vasopressor dosage [ Time Frame: 24, 48, 72 hours ] 

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Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 
h 
4. Fluid substitution and fluid balance [ Time Frame: 24, 48, 72 hours ] 
Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h 
3. 
Length of hospital stay [Time Frame: up to 1 months] 
Days at hospital 
4. 
Mortality [Time Frame: First 72 hours] 
The period of occurrence of mortality 
 
 
Statistical studies  
1) Statistical data processing  
2) Comparison and analysis of source data  
After data receiving, statistical analysis will be performed using SPSS Statistics software 
version 22. For quantitative data, the Mann-Whitney Yu non-parametric test and parametric t-test 
will be performed, and Fisher's non-parametric exact test and χ2 parametric test will be performed 
for qualitative studies. Also, a logistic regression for categorical outcomes and a survival analysis 
(non-parametric Kaplan-Meier and parametric Cox regression) will be performed. 
Ages:18 Years and older  
Sex: All 
Accepts healthy volunteers:  
No 
 
Groups 
Inclusion criteria 
Exclusion Criteria: 
ICU patients with 
ECMO  
• Hemodynamic 
support 
with 
vasopressors 
• Procalcitonin level ≥ 1 ng/ml 
• Invasive 
hemodynamic 
monitoring 
• Written informed content 
 age < 18 years 
 acute liver or kidney failure 
straight before transplantation 
 the patient declines participating 
in the study 
ICU patients with 
septic 
shock 
of 
medical origin 
• Signs of hypoperfusion: serum 
lactate >2 mmol/L, low central 
venous oxygen saturation (ScvO2) 
(<70%) or high ScvO2 (>85%), 
metabolic 
acidosis, 
oligo-anuria, 
 Patients under 18 years 
 Pregnancy 
(bHCG 
test 
positivity) 
 Surgical 
intervention 
in 
context with the septic insult 

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high 
venous-to-arterial 
CO2-gap 
(dCO2 >6 mm Hg) 
• Hemodynamic 
support 
with 
vasopressors 
• Procalcitonin level ≥ 1 ng/ml 
• Invasive 
hemodynamic 
monitoring 
• Written informed content 
New York Heart Association 
IV heart failure 
 Acute coronary syndrome 
 Acute 
haematological 
malignancies 
 Immunosuppression, systemic 
steroid 
therapy 
(>10mg 
prednisolon/day) 
 Human 
immunodeficiency 
virus infection (HIV) and 
active AIDS 
 Patients with donated organs 
 Thrombocytopenia 
(<20.000/ml) 
 More 
than 
10%-of 
body 
surface area with third degree 
burn 
 
Study will be conducted in accordance with international standards of Good Clinical 
Practice, Joint Commission International, Scientific Ethics (Helsinki Declaration), as well as the 
Order of the Minister of Health of the Republic of Kazakhstan April 2, 2018 No. 142 “On approval 
of the Rules for conducting biomedical experiments, preclinical (nonclinical) and clinical studies, as 
well as requirements for preclinical and clinical bases”. It will also take place according to the 
recommendations of the Local Ethical Commission at the NSCC. All patients will receive voluntary 
informed consent of the established sample with permission to use clinical data for scientific 
purposes. In addition, the study will be strictly controlled by researchers for the absence of 
plagiarism, falsification and fabrication of data in order to achieve the most ethical conduct of the 
study. The obtained patient data will be kept strictly confidential, ensuring privacy by strictly 
limited access to data, de-identification of data and destruction after the end of the study. 
 
 
 
 
 

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5. Planning and program management 
 
№ 
Name 
Position 
Directions of work in the project 
% of 
project 
involvement 
1 
Timur  
Lesbekov  
Principal 
investigator 
Principal investigator of the project. 
General project management, definition of the 
vision and direction of the project, 
participation in the analysis of results, 
participation in the preparation of publications 
50% 
2 
 
Rymbay  
Kaliyev  
Senior 
researcher 
Definition of the vision and direction of the 
project, participation in the analysis of results, 
participation in the preparation of publications. 
50% 
3 
Zhuldyz 
Nurmykhametova  
Middle 
researcher 
Patient selection, analysis of clinical data, 
development of a questionnaire of quality of 
life. Participation in the analysis of results and 
preparation of publications, methods, including 
methods of prevention. 
50% 
4 
 
Ainel 
Iskakova  
 
Junior 
researcher 
Participation in the analysis of results and 
preparation of publications, methods, including 
methods of prevention. 
50% 
5 
 
Roza 
Ayapbergenova 
Junior 
researcher 
Selection of patients, conducting clinical 
studies, filling out the cards of project 
participants, obtaining informed consent, 
analysis of clinical data, participation in the 
preparation of publications. 
50% 
6 
Aydyn                     
Kuanyshbek 
Junior 
researcher 
Selection of patients, conducting clinical 
studies, filling out the cards of project 
participants, obtaining informed consent, 
analysis of clinical data, participation in the 
preparation of publications. 
50% 
 
 

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Project involves 6 specialists in the field of cardiac surgery, perfusion, cardiology, 
anesthesiology, efferentology, and public health. 
Principal Investigato - Timur Dostaevich Lesbekov, Candidate of Medical Sciences, Head of 
the Department of Cardiac Surgery, JSC National Scientific Cardiac Surgery Center. According to 
Scopus, the Hirsch index is 2, the Author ID in Scopus is 6505523476. 
Kaliev Rymbay Bolatovich - Head of the Operations Department with the Laboratory of 
Assisted Circulation of the National Scientific Cardiac Surgery Center JSC. According to Scopus, 
the Hirsch index is 2, the Author ID in Scopus is 57053326800. 
Nurmykhametova Zhuldyz Askarovna - doctor perfusionist of the operating department with 
the laboratory of auxiliary circulation of the JSC "National Scientific Cardiac Surgery Center". 
According to Scopus, the Hirsch index is 2, the Author ID in Scopus is 57194187404. 
 
 International publications: 
1 
Kaliyev, R., Lesbekov, T., Bekbossynov, S. Samalavicius, R., Pya, Y. 
Comparison of Custodiol vs warm blood cardioplegia and conditioning of donor hearts 
during transportation with the organ care system//Journal of Cardiac 
Surgery, 2019, 34(10), с. 969-975 
2 
R. Kaliyev, S. Bekbossynov, Zh. Nurmykhametova. Sixteen‐Hour Ex Vivo Donor 
Heart 
Perfusion 
During 
Long‐Distance 
Transportation 
for 
Heart 
Transplantation//Artificial organs – 43(3), 2019, с. 319-320 
3 
Пя Ю.В., Калиев Р.Б., Лесбеков Т.Д., Бекбосынов С.Т., Капышев Т.С., 
Нурмыхаметова Ж.А., Смагулов Н.К., Аширов Ж.З., Фаизов Л.Р. Программа 
экстракорпоральной мембранной оксигенаций в Казахстане: ближайшие 
результаты 
// 
«Журнал 
им. 
акад. 
Б.В. 
Петровского 
Клиническая 
и 
экспериментальная хирургия» - №1-2017 г. С. 41-45 
4 
Пя Ю.В., Калиев Р.Б., Бекбосынов С.Т., Лесбеков Т.Д., Нурмыхаметова Ж.А., 
Смагулов Н.К., Новикова С.П., Аширов Ж.З., Фаизов Л.Р., Медресова А.Т., 
Мурзагалиева 
М.О. 
Новый 
метод 
сохранения 
донорского 
сердца 
с 
использованием кровяной кардиоплегии и кондиционирования // «Журнал им. 
акад. Б.В. Петровского Клиническая и экспериментальная хирургия» - №3-2017 г. 
С. 54-60   

14 
 
5 
Пя Ю.В., Бекбосынов С.Т., Бекбосынова М.С., Куатбаев Е.М.,Лесбеков Т.Д., 
Калиев 
Р.Б., 
Джетыбаева 
С.К., 
Медресова 
А.Т.,Нурмыхаметова 
Ж.А., 
Мурзагалиев М.У., Новикова С.П., Капышев Т.С.,Смагулов Н.К., Фаизов Л.Р., 
Вахрушев И.А., Андосова С.А.,Мырзахметова Г.Ш., Надирбекова Г.Е., 
Шайсултанова С.Т., Дюсенбина Ж.С. Программа трансплантации сердца в эпоху 
механической поддержки кровообращения: опыт Республики Казахстан // 
«Журнал им. акад. Б.В. Петровского Клиническая и экспериментальная 
хирургия» - №3-2017 г. С. 49-54 
6 
Kaliyev, R., Kapyshev, T., Goncharov, A., Lesbekov, T., Pya, Y. 
Maternal and fetal recovery after severe respiratory failure: A case report of air 
transportation of a pregnant woman on ECMO using the CentriMag transporter 
system//ASAIO Journal, 2015, 61(5), с. e33-e35 
7 
Shneǐder, I.A., Lesbekov, T.D., Kuznetsov, K.V.,Rogacheva, N.M., Iuferov, A.P. 
Coronary endarterectomy during off-pump coronary artery bypass surgery// 
Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery, 2008, 14(3), с. 
101-106 
8 
Shneǐder, I.A., Lesbekov, T.D., Kuznetsov, K.V.,Aleshin, N.G., Tsoǐ, M.D. 
Coronary artery of the heart reconstructions after endarterectomy//Vestnik khirurgii 
imeni I. I. Grekova, 2006, 165(5), с. 17-20 
 
6. Project implementation plan 
 
 
№ 
i/n 
Name of task, 
activities for 
implementation of 
project tasks 
Duration 
(in months)
Start and 
end date of  
work * (dd 
/ mm / yy). 
Years of project implementation, expected 
project results (in terms of tasks and 
activities) 
2021 
2021 
2022 
1. 
Literature review on 
treatment of patients 
with failure of heart 
and lung within 
innovation technolog 
6 months 
01.01.2021-
01.06.2021 
 
 
 
1.1 
Literature review of 
patients on ECMO 
with using 
extracorporeal 
cytokine adsorber or 
hemoperfusion 
cartridge  
 
 
Literature 
review for 
ECMO patients 
using an 
extracorporeal 
cytokine 
adsorber and an 
extracorporeal 
 
 

15 
 
hemoperfusion 
cartridge. 
Obtaining the 
results of the 
literary review. 
1.2 
Literature review of 
septic patients with 
using extracorporeal 
cytokine adsorber or 
hemoperfusion 
cartridge  
 
 
Literature 
review for 
septic patients 
using an 
extracorporeal 
cytokine 
adsorber and an 
extracorporeal 
hemoperfusion 
cartridge will 
be conducted. 
Obtaining the 
results of the 
literary review. 
 
 
2. 
Recruiting patients on 
ECMO / septic patients 
with using 
extracorporeal 
cytokine adsorber or 
hemoperfusion 
cartridge depend of 
diagnosis  
36 months 01.01.2021-
31.12.2023 
Initial patient 
condition will 
be studied  
Initial patient 
condition will 
be studied 
Initial 
patient 
condition 
will be 
studied 
2.1 
Examination of 
patients, verification of 
diagnosis and other 
procedure   
 
 
 
 
 
2.2 
Study of directly 
clinical results of after 
using extracorporeal 
adsorbent on ECMO 
patients    
 
 
 
 
 
2.3 
Study of directly 
clinical results of after 
using extracorporeal 
adsorbent on patients 
with sepsis.    
 
 
 
 
 
3. 
Clinical and 
laboratory data will be 
analyzed on basis of 
clinical research 
12 months 01.01.2023- 
31.12.2023 
 
 
A protocol 
will be 
developed 
and 
optimized 
for the 
implementat
ion of 

16 
 
extracorpor
eal adsorber 
technologie
s for this 
category of 
patients 
3.1 
A protocol for 
optimization of 
introduction novel 
technology will be 
developed and 
implemented  
 
 
 
 
 
3.2. 
Protocol 
implementation 
 
 
 
 
 
4. 
Preparation of 
publications, reports, 
development of 
methodological 
guidelines 
24 months 2022-2023 
 
Article in 
international 
and local 
journals 
Article in 
internationa
l and local 
journals 
5. 
Creation of 
intermediate and final 
reports 
annually 
2021-202 
3 
Interim and 
final reports 
will be 
generated 
Interim and 
final reports 
will be 
generated. 
Interim and 
final reports 
will be 
generated. 
 
 
8. Expected results 
 
The data of the Ministry of Health of the Republic of Kazakhstan show that annually in the 
country of terminal cardiac and pulmonary insufficiency is detected in 110-120 thousand people a 
year. 
The clinical trial data will form the basis of practical protocols for extracorporeal membrane 
oxygenation (ECMO) and septic patients, the follow-up of which will improve organ repair, reduce 
postoperative complications, reduce mortality after surgery and improve quality of life. 
The research results will be published in at least 3 (three) articles and (or) reviews in peer-
reviewed scientific journals indexed in the Science Citation Index Expanded of the Web of Science 
database and (or) having a CiteScore percentile in the Scopus database of at least 35 (thirty five) , as 
well as in at least 1 (one) article or review in a peer-reviewed foreign or domestic edition 
recommended by the Committee for Monitoring in Education and Science of the Ministry of 
Education and Science of the Republic of Kazakhstan. 

17 
 
The results of a clinical study will improve the effectiveness of surgical treatment and reduce 
the level of complications and mortality, improve the quality of life of patients undergoing cardiac 
surgery. The introduction of a clinical protocol for the use of an extracorporeal adsorbent in this 
category of patients will allow standardizing this technique in the Republic of Kazakhstan. 
The data obtained on the treatment of patients with heart and lung failure and organ 
restoration through the use of innovative technologies will provide the necessary information to 
improve the quality of tertiary care and the quality of life of patients in Kazakhstan and around the 
world. The developed methods can be used as new standards and recommendations both 
domestically and abroad through successful presentations at various conferences. If there are unique 
developments in the use of an extracorporeal adsorbent, patent applications will be filed. 
In general, the expected effectiveness and efficiency of the proposed project will make a 
significant contribution to the development of transplantation, cardiac surgery and cardiology in 
Kazakhstan. In addition, the effective distribution of budgetary funds in accordance with the articles 
and amounts of expenditures will allow maximally concentrating the expenditure side of the 
implementation of this project to achieve the stated goals and objectives. 
 
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