Quality control of laboratory parameters of the thrombodynamics test in real clinical practice: cross-sectional study

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BACKGROUND: In-laboratory quality control determines the correctness and reliability of research. Coagulological research should comply with the general requirements for the standardization of clinical and laboratory studies developed by the International Organization for Standardization, World Health Organization, and Ministry of Health of Russia.

AIM: To verify the integral method of studying the hemostasis system, namely, “thrombodynamics,” and its successful use in real clinical practice.

MATERIALS AND METHODS: This study used citrate fresh plasma obtained from 14 patients according to the standard rules of blood collection and in compliance with all conditions of the pre-analytical stage for coagulological studies and commercial pooled plasma.

RESULTS: The coefficients of variation (individual and group) for the hypo, normo, and hyper models were ≤10%, indicating that the analytical characteristics obtained in the laboratory correspond to the recommended characteristics of the manufacturer. A sample preparation algorithm of three levels has been developed for commercial control of plasmas.

CONCLUSION: The thrombodynamics test enables obtaining information about the risks of bleeding and thrombosis and evaluating the effectiveness of anticoagulant therapy with heparins.

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作者简介

Olga Startseva

Nikiforov Russian Center of Emergency and Radiation Medicine

编辑信件的主要联系方式.
Email: startceva@mail.ru
ORCID iD: 0000-0003-3524-3603
SPIN 代码: 3817-5670

Cand. Sci. (Biology)

俄罗斯联邦, 4/2 Academic Lebedev Str., St. Petersburg, 194044

参考

  1. Dolgov VV, Vavilova TV, Svirin PV. Laboratory diagnosis of hemostasis disorders. Moscow: Triada, 2019. (In Russ).
  2. Sinauridze EL, Vuimo TA, Tarandovskiy ID, et al. Thrombodynamics a new global coagulation test: Measurement of heparin efficiency. Talanta. 2018,180:282–291. doi: 10.1016/j.talanta.2017.12.055
  3. Gracheva MA, Balandina AN, Ataullakhanov FI, Roitman EV. Comparison of responses of integrated and screening tests for hemostasis assessment to various coagulation states in models in vitro. Tromboz, gemostaz i reologia. 2016,(4(68)):64–71. EDN: XAGIWP
  4. Soshitova NP, Karamzin SS, Balandina AN, et al. Predicting prothrombotic tendencies in sepsis usingspatial clot growth dynamics. Blood Coagul Fibrinolysis. 2012,23(6):498–507. doi: 10.1097/MBC.0b013e328352e90e
  5. Gracheva MA, Urnova ES, Sinauridze EI, et al. Thromboelastography, thrombin generation test and thrombodynamics reveal hypercoagulability inpatients with multiple myeloma. Leuk Lymphoma. 2015,56(12):3418–3425. doi: 10.3109/10428194.2015.1041385
  6. Koltsova EM, Balandina AN, Grischuk KI, et al. The laboratory control of anticoagulant thromboprophylaxis during the early postpartum period after cesarean delivery. J Perinat Med. 2018,46(3):251–260. doi: 10.1515/jpm-2016-0333
  7. Balandina AN, Koltsova EM, Shibeko AM, Kuprash AD, Ataullakhanov FI. Thrombodynamics: a new method to the diagnosis of hemostasis system disorders. Pediatric Hematology/Oncology and Immunopathology. 2018,17(4):114–126. EDN: QQQHBE doi: 10.24287/1726-1708-2018-17-4-114-126
  8. Dashkevich NM, Vuimo TA, Ovsepyan RA, et al. Effect of Pre-Analytical Conditions on the Thermodynamics Assay. Тhrombosis Research. 2014,133(3):472–476. doi: 10.1016/j.thromres.2013.12.014
  9. Wu T, Xia X, Chen W, Fu J, Zhang J. The effect of anti-Xa monitoring on the safety and efficacy of low-molecular-weight heparin anticoagulation therapy: A systematic review and meta-analysis. Journal of Clinical Pharmacy and Therapeutics. 2020,45(4):602–608. doi: 10.1111/jcpt.13169
  10. Startseva ON, Vavilova TV, Kornev VI, Zybina NN. Laboratory evaluation of the anticoagulant therapy effect: comparative characteristics of the thrombodynamics assay and anti-Xa activity measurement. Preventive and clinical medicine. 2023,(2(87)):97–102. EDN: WLXWGW doi: 10.47843/2074-9120_2023_2_97
  11. Salukhov VV, Kryukov EV, Varavin NA, Startseva ON. Comparison of thrombodynamic tests with determination of anti-Xa activity in evaluation of the efficacy of anticoagulant therapy in patients suffering deep vein thrombosis of the lower extremities. Bulletin of the Russian Military Medical Academy. 2024,26(1):79–86. doi: 10.17816/brmma568480
  12. Balandina AN, Serebriyskiy II, PoletaevAV, et al. Thrombodynamics — a new global hemostasis assay for heparin monitoring in patients under the anticoagulant treatment. PLoSOne. 2018,13(6). doi: 10.1371/journal.pone.0199900

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2. Fig. 1. Design of the study.

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3. Fig. 2. Distribution of anti-Xa activity concentration and clot growth parameter in the “hypo” model.

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4. Fig. 3. Concentrations of factor VIII and Willebrand factor, as well as the time of spontaneous thrombosis in the “hyper” model.

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5. Fig. 4. Control map of the "clot growth rate" parameter. The study was performed on a commercial plasma from Instrumentation Laboratory with normal values, lot N. 0495003. The selected points — samples without prior centrifugation.

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6. Fig. 5. Control map of the parameter "initial clot growth rate". The study was performed on a commercial plasma from Instrumentation Laboratory with normal values, lot N. 0495003. The selected points — samples without prior centrifugation.

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7. Fig. 6. Control map of the "clot size" parameter. The study was performed on a commercial plasma from Instrumentation Laboratory with normal values, lot N. 0495003. The selected points — samples without prior centrifugation.

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8. Fig. 7. Control map of the "clot density" parameter. The study was performed on commercial plasma from Instrumentation Laboratory with normal values, lot N. 0495003. The selected points are samples without prior centrifugation.

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9. Fig. 8. Control map of the "clot growth rate" parameter. The study was performed on commercial plasma from Bio-Rad, level 2, lot N. 84732.

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10. Fig. 9. Control chart of the parameter "initial clot growth rate". The study was performed on commercial plasma of Bio-Rad company, level 2, lot N. 84732.

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11. Fig. 10. Control map of the "clot size" parameter. The study was performed on commercial plasma from Bio-Rad, level 2, lot N. 84732.

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12. Fig. 11. Control map of the "clot density" parameter. The study was performed on commercial plasma from Bio-Rad, level 2, lot N. 84732.

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