ClinicalTrials.gg
Status unknownNCT05090930Updated Oct 25, 2021

Innovative Technologies for the Treatment of Pulmonary and Heart Failure

An interventional study of HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection and CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber in Cardiogenic Shock, Ventricular Arrythmia and Cardiac Arrest With Successful Resuscitation, sponsored by National Research Center for Cardiac Surgery, Kazakhstan. Status unknown at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by National Research Center for Cardiac Surgery, Kazakhstan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the program. Formulation of new treatments for heart and pulmonary failure through using organ-replacing technologies.

Formulation of a clinical protocol and implementation of treatment methods into clinical practice heart and pulmonary failure using organ-replacing technologies.

New methods were created for rehabilitating the function of affected organs after implantation of the LVAD, a total artificial heart, an extracorporeal life-sustaining system will be of great importance, both for Kazakhstan and for states with similar problems of donor organ deficiency, will also improve the effectiveness of surgical treatment and reduce the level of complications and mortality of patients on the extracorporeal life-sustaining system and septic patients.

Read the detailed description

Objectives of the program. Task 1. Assessment of the results of the use of extracorporeal life support systems in the treatment of pulmonary and/or heart failure.

Subtask 1.1. Assessment of the restoration of organ function during extracorporeal life support systems using extracorporeal hemocorrection.

Subtask 1.2. Assessment of the normalization of the body's immune response and restoration of organ function during extracorporeal life support systems using an extracorporeal cytokine adsorber.

Task 2. Studying the restoration of organ function during implantation of the left ventricular assist device as an organ-replacing aid in heart failure.

Subtask 2.1. Assessment of the restoration of organ function during implantation of the left ventricular assist device with the use of extracorporeal hemocorrection.

Subtask 2.2. Assessment of the normalization of the body's immune response and restoration of organ function upon implantation of the left ventricular assist device using an extracorporeal cytokine adsorber.

Task 3. Studying the restoration of organ function during the implantation of the total artificial heart as an organ-replacing aid in case of heart failure.

Task 3.1. Assessment of normalization of organ function restoration during implantation of the total artificial heart with the use of extracorporeal hemocorrection.

Task 4. Studying the restoration of organ function during operations in conditions of the long-term cardiopulmonary bypass.

Task 4.1. Assessment of the restoration of organ function during operations with long-term cardiopulmonary bypass, hypothermia, and circulatory arrest, with the use of extra corporeal hemocorrection.

Task 4.2. Assessment of the restoration of organ function during operations with long-term cardiopulmonary bypass, hypothermia, and circulatory arrest using an extracorporeal cytokine adsorber.

Task 5. Improvement of the method of implantation of organ-replacing technologies to reduce complications in the treatment of heart and pulmonary failure.

Study design. Study type: interventional (clinical study) Set of participants: 100 participants Distribution: randomized Interventional model: parallel Masking: no Primary Goal: Treatment

02

Conditions studied

  • Cardiogenic Shock
  • Ventricular Arrythmia
  • Cardiac Arrest With Successful Resuscitation
  • Sepsis
  • Multiple Organ Failure
  • Pulmonary Failure
  • Decompensated Heart Failure
  • Acute Heart Failure

Keywords

  • Anesthesiology
  • Cardiothoracic surgery
  • Nephrology
  • Perfusion
  • Efferentology
03

In context

Shock, Cardiogenic

296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

National Research Center for Cardiac Surgery, Kazakhstan is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients on an extracorporeal life support system with heart failure:

  • Implantation of intravenous ECMO
  • Hemodynamic support with vasopressors and/or tonics;
  • Procalcitonin level ≥ 1 ng/ml;
  • Invasive hemodynamic monitoring;
  • Written .

Patients on an extracorporeal life support system with pulmonary failure:

  • IV ECMO implantation
  • High levels of venous and arterial CO2 (CO2> 50 mmHg),
  • Low paO2, SvO2, SpO2.
  • Invasive hemodynamic monitoring;
  • Written informed consent.

    -Patients with left ventricular assistive device implantation:

  • LVAD implantation
  • Biventricular heart failure IV
  • INTERMACS I-III
  • Hemodynamic support with vasopressors and/or tonics;
  • Procalcitonin level ≥ 0.1 ng/ml;
  • Invasive hemodynamic monitoring;
  • Written informed consent.

    -Patients in operations with prolonged artificial circulation, hypothermia and circulatory arrest:

  • Hemodynamic support with vasopressors and/or tonics;
  • Bypass duration> 120 minutes
  • Hypothermia ≤ 25 0С
  • Circulatory arrest
  • Procalcitonin level ≥ 1 ng/ml;
  • Invasive hemodynamic monitoring;
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients on an extracorporeal life support system with heart failure:

    • Age less than 18 years old
    • Terminal hepatic or renal failure just before the procedure
    • Patient's written refusal to participate in the study
  • Patients on an extracorporeal life support system with pulmonary failure:

    • Age less than 18 years old
    • Terminal hepatic or renal failure just before the procedure
    • Patient's written refusal to participate in the study
  • Patients with left ventricular assistive device implantation:

    • Age less than 18 years old
    • Acute hepatic or renal failure just before the procedure
    • Patient's written refusal to participate in the study
  • Patients in operations with prolonged artificial circulation, hypothermia and circulatory arrest:

    • Age less than 18 years old
    • Terminal hepatic or renal failure just before the procedure
    • Patient's written refusal to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Intervention team (1/1 group)

    An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure... (10 patients)

    Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

  • Active comparator
    Intervention team (1/2 group)

    An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for pulmonary failure (10 patients).

    Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

  • Active comparator
    Intervention team (1/3 group)

    An extracorporeal hemoperfusion device will be installed in patients before/during the implantation of a left ventricular accessory (5 patients).

    Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

  • Active comparator
    Intervention team (1/4 group)

    An extracorporeal hemoperfusion device will be installed in patients during operations with prolonged artificial circulation, hypothermia, and circulatory arrest. (25 patients).

    Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

  • Active comparator
    Intervention team (2/1 groups)

    An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure. (10 patients)

    Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

  • Active comparator
    Intervention team (2/2 groups)

    An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for pulmonary failure. (10 patients)

    Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

  • Active comparator
    Intervention team (2/3 groups)

    An extracorporeal hemoperfusion device will be installed in patients before/during the implantation of a left ventricular accessory (5 patients)

    Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

  • Active comparator
    Intervention team (2/4 groups)

    An extracorporeal hemoperfusion device will be installed in patients during operations with prolonged artificial circulation, hypothermia, and circulatory arrest. (25 patients)

    Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

Interventions

  • DeviceHA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

    HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, which is based on the removal of cytokines from whole blood by sorption on a special hemoadsorbent due to the peculiarities of its porous structure and inner surface, which is indicated in conditions where cytokine levels are extremely elevated

  • DeviceCytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

    CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber is a biocompatible polymer with high adsorption capacity, which is indicated in conditions where cytokine levels are extremely elevated

06

What researchers measure

Primary outcomes

  1. Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response

    The level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor alpha-factor) before the start, 2 hours after the start of ECMO support, when ECMO is turned off, 24 hours after ECMO is turned off.

    Time frame: 24-48 hours

  2. Extracorporeal life support system with pulmonary and / or heart failure: SOFA-Score

    Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)

    Time frame: 24, 48, 72 hours

  3. Extracorporeal life support system with pulmonary and / or heart failure

    Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)

    Time frame: Time: first 72 hours

  4. Patients with left ventricular assist device implantation: Difference of Cytokine response

    Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin)

    Time frame: 24-48 hours

  5. Patients with left ventricular assist device implantation:vasopressors and / or inotropes

    Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)

    Time frame: first 72 hours

  6. Patients with left ventricular assist device implantation:Renal function

    creatinine level

    Time frame: first 72 hours

  7. Patients with left ventricular assist device implantation:Lactate level

    Lactate level

    Time frame: first 72 hours

  8. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of Cytokine response

    Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin, C-reactive protein)

    Time frame: 24-48 hours

  9. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: SOFA-Score

    Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)

    Time frame: 24, 48, 72 hours

  10. Extracorporeal life support system with pulmonary and / or heart failure:Difference of mean arterial pressure

    Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)

    Time frame: 24, 48, 72 hours

  11. Extracorporeal life support system with pulmonary and / or heart failure: Difference of CVP

    Comparison of CVP at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)

    Time frame: 24, 48, 72 hours

  12. Extracorporeal life support system with pulmonary and / or heart failure: Serum lactate

    Level of serum lactate at 24, 48, 72 h

    Time frame: 24, 48, 72 hours

  13. Extracorporeal life support system with pulmonary and / or heart failure:Days on ventilator, vasopressor and renal replacement therapy

    Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed

    Time frame: until day 30 post-surgery

  14. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of mean arterial pressure

    Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)

    Time frame: 24, 48, 72 hours

  15. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP

    Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)

    Time frame: 24, 48, 72 hours

  16. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Level of Serum lactate

    Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)

    Time frame: 24, 48, 72 hours

Secondary outcomes

  1. Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)

    The level of C-reactive protein (CRP) before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.

    Time frame: 24-48 hours

  2. Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte

    Level of leukocyte cells in the bloodstream at 24, 48 hours

    Time frame: 24-48 hours

  3. Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors

    Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery

    Time frame: first 48 hours

  4. Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)

    The level of C-reactive protein (CRP) before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation

    Time frame: 24-48 hours

  5. Patients with left ventricular assist device implantation: Application and dosage of vasopressors

    Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery

    Time frame: first 48 hours

  6. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)

    The level of C-reactive protein (CRP) before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.

    Time frame: 24-48 hours

  7. For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function

    Leukocyte function: heterogeneity of the population of leukocyte cells in the bloodstream

    Time frame: first 48 hours

  8. For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors

    Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery

    Time frame: first 48 hours

  9. Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes

    The level of leukocytes before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation

    Time frame: 24-48 hours

  10. Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin

    The level of procalcitonin before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.

    Time frame: 24-48 hours

  11. Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes

    Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery

    Time frame: first 48 hours

  12. Patients with left ventricular assist device implantation: The level of leukocytes

    The level of leukocytes before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation

    Time frame: 24-48 hours

  13. Patients with left ventricular assist device implantation: The level of procalcitonin

    The level of procalcitonin before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation

    Time frame: 24-48 hours

  14. Patients with left ventricular assist device implantation: Application and dosage of inotropes

    Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery

    Time frame: first 48 hours

  15. For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes

    The level of leukocytes before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.

    Time frame: 24-48 hours

  16. For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin

    The level of procalcitonin before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.

    Time frame: 24-48 hours

  17. For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes

    Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery

    Time frame: first 48 hours

Other outcomes

  1. Length of stay

    Length of stay in the intensive care unit

    Time frame: first 48 hours

  2. Length of hospital stay

    Length of hospital stay

    Time frame: up to 1 month

  3. 30 day survival rate.

    30 day survival rate.

    Time frame: 30 day

07

Study locations

1 of 1 sites recruiting
  • National Research Center For Cardiac Surgery
    Astana, 010000, Kazakhstan
    Recruiting
08

References and documents

Publications

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  • Nemeth E, Kovacs E, Racz K, Soltesz A, Szigeti S, Kiss N, Csikos G, Koritsanszky KB, Berzsenyi V, Trembickij G, Fabry S, Prohaszka Z, Merkely B, Gal J. Impact of intraoperative cytokine adsorption on outcome of patients undergoing orthotopic heart transplantation-an observational study. Clin Transplant. 2018 Apr;32(4):e13211. doi: 10.1111/ctr.13211. Epub 2018 Feb 27. Erratum In: Clin Transplant. 2019 Jun;33(6):e13556. doi: 10.1111/ctr.13556.. Abstract corrected. PubMed 29377282 ↗
  • Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Laszlo I, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A prospective observational study. J Crit Care. 2016 Aug;34:50-5. doi: 10.1016/j.jcrc.2016.04.007. Epub 2016 Apr 13. PubMed 27288610 ↗
  • Riedel S. Procalcitonin and the role of biomarkers in the diagnosis and management of sepsis. Diagn Microbiol Infect Dis. 2012 Jul;73(3):221-7. doi: 10.1016/j.diagmicrobio.2012.05.002. PubMed 22704255 ↗
  • Nylen ES, Whang KT, Snider RH Jr, Steinwald PM, White JC, Becker KL. Mortality is increased by procalcitonin and decreased by an antiserum reactive to procalcitonin in experimental sepsis. Crit Care Med. 1998 Jun;26(6):1001-6. doi: 10.1097/00003246-199806000-00015. PubMed 9635646 ↗
  • Schadler D, Pausch C, Heise D, Meier-Hellmann A, Brederlau J, Weiler N, Marx G, Putensen C, Spies C, Jorres A, Quintel M, Engel C, Kellum JA, Kuhlmann MK. The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial. PLoS One. 2017 Oct 30;12(10):e0187015. doi: 10.1371/journal.pone.0187015. eCollection 2017. PubMed 29084247 ↗
  • Trasy D, Molnar Z. Procalcitonin - Assisted Antibiotic Strategy in Sepsis. EJIFCC. 2017 May 1;28(2):104-113. eCollection 2017 May. PubMed 28757818 ↗
  • Tschaikowsky K, Sagner S, Lehnert N, Kaul M, Ritter J. Endothelin in septic patients: effects on cardiovascular and renal function and its relationship to proinflammatory cytokines. Crit Care Med. 2000 Jun;28(6):1854-60. doi: 10.1097/00003246-200006000-00028. PubMed 10890632 ↗
  • Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available. Erratum In: Circulation. 2018 Mar 20;137(12):e493. doi: 10.1161/CIR.0000000000000573. PubMed 29386200 ↗
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Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Yes: There is a plan to make IPD and related data dictionaries available.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: from October 2021 year and will become available till December 2023 year.

Access criteria: The resulting patient data will be strictly confidential with ensuring privacy through strictly limited access to data, de-identification of data and destruction after the end of the study.

Data sharing details ↗ · heartcenter.kz

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Jul 2023, 30 months after the start.

Of 49 non-industry interventional studies with no phase under Shock, Cardiogenic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 30 months is below that.

Counting every sponsor, half of 53 studies reached it within 39 months; a quarter within 24 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2021
First posted
Oct 25, 2021
StartActual
Jan 1, 2021
Primary completionEst.
Jul 1, 2023
CompletionEst.
Dec 1, 2023
Last update
Oct 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05090930
Lead sponsor
National Research Center for Cardiac Surgery, Kazakhstan
Collaborators
Ministry of Education and Science, Republic of Kazakhstan
Responsible party
Yuriy Pya (Director for Surgery and Science, National Research Center for Cardiac Surgery, Kazakhstan) — Principal investigator
First posted
Oct 25, 2021
Start date
Jan 1, 2021
Primary completion
Jul 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Oct 25, 2021

Study contacts

Yuri Pya, PhD, MD
Contact
rp.nrcsc@gmail.com
+77172272090
Timur Lesbekov, MD
Contact
lesbekovt@mail.ru
+77172703100
Yuri Pya, PhD, MD
principal investigator · National research Center for Cardiac Surgery JSC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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