Clinical utility of viscoelastic testing (TEG and ROTEM analyzers) in the management of old and new therapies for hemophilia

American Journal of Hematology

Volumn 94, Issue 2, 2019, Pages 249-256

  Ramiz, Sarah ^a   Hartmann, Jan ^b   Young, Guy ^c   Escobar, Miguel A ^d   Chitlur, Meera ^a  

^a WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HAEMONETICS CORPORATION   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d UNIVERSITY OF TEXAS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 8; EMICIZUMAB; VISCOELASTIC SUBSTANCE;

ACTIVATED PARTIAL THROMBOPLASTIN TIME; BLEEDING; CLINICAL FEATURE; HEMOPHILIA; HEMOPHILIA A; HUMAN; PATIENT CARE; PERIOPERATIVE PERIOD; PHENOTYPE; PRIORITY JOURNAL; PROPHYLAXIS; PROTHROMBIN TIME; REVIEW; THROMBOELASTOGRAPHY; TREATMENT RESPONSE; VISCOELASTICITY; DEVICES; DISEASE MANAGEMENT; HEMOPHILIA B; PROCEDURES;

DISEASE MANAGEMENT; HEMOPHILIA A; HEMOPHILIA B; HUMANS; THERAPEUTICS; THROMBELASTOGRAPHY; VISCOELASTIC SUBSTANCES;

EID: 85058083726     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.25319     Document Type: Review

References (44)

1. Hartert H. Blutgerinnungsstudien mit der Thrombelastographie; einem neuen Untersuchungs verfahren. Klin Wochenschr. 1948;26(37–38):577-583.
2. Nogami K. The utility of thromboelastography in inherited and acquired bleeding disorders. Br J Haematol. 2016;174(4):503-514. https://doi.org/10.1111/bjh.14148.
3. Whiting D, DiNardo JA. TEG and ROTEM: technology and clinical applications. Am J Hematol. 2014;89(2):228-232. https://doi.org/10.1002/ajh.23599.
4. Chitlur M, Simpson ML. Role of global assays in thrombosis and thrombophilia. In: Goldenberg NA, Manco-Johnson MJ, eds. Pediatric Thrombotic Disorders. Cambridge: Cambridge University Press; 2014:142-157. https://doi.org/10.1017/CBO9781139028882.012.
5. Young G, Sorensen B, Dargaud Y, Negrier C, Brummel-Ziedins K, Key NS. Thrombin generation and whole blood viscoelastic assays in the management of hemophilia: current state of art and future perspectives. Blood. 2013;121(11):1944-1950. https://doi.org/10.1182/blood-2012-08-378935.
6. Mohammed BM, Martin EJ, Salinas V, Carmona R, Young G, Brophy DF. Failure of corn trypsin inhibitor to affect the thrombin generation assay in plasma from severe hemophiliacs. J Thromb Haemost. 2014;12(9):1558-1561. https://doi.org/10.1111/jth.12659.
7. Chitlur M, Young G. Global assays in hemophilia. Semin Hematol. 2016;53(1):40-45. https://doi.org/10.1053/j.seminhematol.2015.10.001.
8. Bolliger D, Seeberger MD, Tanaka KA. Principles and practice of thromboelastography in clinical coagulation management and transfusion practice. Transfus Med Rev. 2012;26(1):1-13. https://doi.org/10.1016/J.TMRV.2011.07.005.
9. Lancé MD. A general review of major global coagulation assays: thrombelastography, thrombin generation test and clot waveform analysis. Thromb J. 2015;13:1. https://doi.org/10.1186/1477-9560-13-1.
10. Hartmann J, Mason D, Achneck H. Thromboelastography (TEG) point-of-care diagnostic for hemostasis management. Point Care J Near-Patient Test Technol. 2018;17(1):15-22. https://doi.org/10.1097/POC.0000000000000156.
11. Bolton-Maggs PH, Pasi KJ. Haemophilias a and B. Lancet. 2003;361(9371):1801-1809. https://doi.org/10.1016/S0140-6736(03)13405-8.
12. Sorensen B, Ingerslev J. Whole blood clot formation phenotypes in hemophilia a and rare coagulation disorders. Patterns of response to recombinant factor VIIa. J Thromb Haemost. 2004;2(1):102-110. https://doi.org/10.1111/j.1538-7836.2004.00528.x.
13. Chitlur M, Warrier I, Rajpurkar M, et al. Thromboelastography in children with coagulation factor deficiencies. Br J Haematol. 2008;142(2):250-256. https://doi.org/10.1111/j.1365-2141.2008.07063.x.
14. Salinas V, Carmona R, Mohammed BM, Martin EJ, Brophy DF, Young G. Is some better than none: are TEG and TGA profiles different in severe FVIII-deficient patients with inhibitors? Haemophilia. 2015;21(3):398-404. https://doi.org/10.1111/hae.12578.
15. Tarandovskiy ID, Balandina AN, Kopylov KG, et al. Investigation of the phenotype heterogeneity in severe hemophilia a using thromboelastography, thrombin generation, and thrombodynamics. Thromb Res. 2013;131(6):e274-e280. https://doi.org/10.1016/j.thromres.2013.04.004.
16. Bowyer AE, Van Veen JJ, Goodeve AC, Kitchen S, Makris M. Specific and global coagulation assays in the diagnosis of discrepant mild hemophilia a. Haematologica. 2013;98(12):1980-1987. https://doi.org/10.3324/haematol.2013.088088.
17. van Veen JJ, Gatt A, Bowyer AE, Cooper PC, Kitchen S, Makris M. Calibrated automated thrombin generation and modified thromboelastometry in haemophilia a. Thromb Res. 2009;123(6):895-901. https://doi.org/10.1016/j.thromres.2008.09.011.
18. AL Hawaj MA, Martin EJ, Venitz J, et al. Monitoring rFVIII prophylaxis dosing using global haemostasis assays. Haemophilia. 2013;19(3):409-414. https://doi.org/10.1111/hae.12110.
19. Negrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. French FEIBA study group. Factor eight bypassing activity. Thromb Haemost. 1997;77(6):1113-1119.
20. Parameswaran R, Shapiro AD, Gill JC, Kessler CM. HTRS Registry investigators. Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the hemophilia and thrombosis research society Registry. Haemophilia. 2005;11(2):100-106. https://doi.org/10.1111/j.1365-2516.2005.01075.x.
21. Astermark J, Donfield SM, DiMichele DM, et al. A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven comparative (FENOC) study. Blood. 2007;109(2):546-551. https://doi.org/10.1182/blood-2006-04-017988.
22. Hayashi T, Tanaka I, Shima M, et al. Unresponsiveness to factor VIII inhibitor bypassing agents during haemostatic treatment for life-threatening massive bleeding in a patient with haemophilia a and a high responding inhibitor. Haemophilia. 2004;10(4):397-400. https://doi.org/10.1111/j.1365-2516.2004.00924.x.
23. Dunkley SM, Yang K. The use of combination FEIBA and rFVIIa bypassing therapy, with TEG profiling, in uncontrollable bleeding associated with acquired haemophilia A. Haemophilia. 2009;15(3):828-830.
24. Young G, Blain R, Nakagawa P, Nugent DJ. Individualization of bypassing agent treatment for haemophilic patients with inhibitors utilizing thromboelastography. Haemophilia. 2006;12(6):598-604. https://doi.org/10.1111/j.1365-2516.2006.01319.x.
25. Pan-Petesch B, Laguna P, Mital A, et al. Single-dose (270 microg kg[−1]) recombinant activated factor VII for the treatment and prevention of bleeds in haemophilia a patients with inhibitors: experience from seven European haemophilia centres. Haemophilia. 2009;15(3):760-765. https://doi.org/10.1111/j.1365-2516.2008.01968.x.
26. Fernández-Bello I, Stenmo C, Butta N, Lind V, Ezban M, Jiménez-Yuste V. The pharmacokinetics and pharmacodynamics of single-dose and multiple-dose recombinant activated factor VII in patients with haemophilia A or B. Haemophilia. 2017;23:868-876. https://doi.org/10.1111/hae.13312.
27. Escobar M, Brewer A, Caviglia H, et al. Recommendations on multidisciplinary management of elective surgery in people with haemophilia. Haemophilia. 2018;24:1-10. https://doi.org/10.1111/hae.13549.
28. Furukawa S, Nogami K, Ogiwara K, Yada K, Minami H, Shima M. Systematic monitoring of hemostatic management in hemophilia a patients with inhibitor in the perioperative period using rotational thromboelastometry. J Thromb Haemost. 2015;13(7):1279-1284. https://doi.org/10.1111/jth.12987.
29. Croteau SE, Abajas YL, Wolberg AS, et al. Recombinant porcine factor VIII for high-risk surgery in paediatric congenital haemophilia A with high-titre inhibitor. Haemophilia. 2017;23(2):e93-e98. https://doi.org/10.1111/hae.13157.
30. Pivalizza EG, Escobar MA. Thrombelastography-guided factor VIIa therapy in a surgical patient with severe hemophilia and factor VIII inhibitor. Anesth Analg. 2008;107(2):398-401. https://doi.org/10.1213/ane.0b013e31817b7864.
31. Fogarty PF, Mancuso ME, Kasthuri R, et al. Presentation and management of acute coronary syndromes among adult persons with haemophilia: results of an international, retrospective, 10-year survey. Haemophilia. 2015;21(5):589-597. https://doi.org/10.1111/hae.12652.
32. Tang M, Wierup P, Terp K, Ingerslev J, Sørensen B. Cardiac surgery in patients with haemophilia. Haemophilia. 2009;15(1):101-107.
33. Misgav M, Mandelbaum T, Kassif Y, Berkenstadt H, Tamarin I, Kenet G. Thromboelastography during coronary artery bypass grafting surgery of severe hemophilia a patient—the effect of heparin and protamine on factor VIII activity. Blood Coagul Fibrinolysis. 2017;28(4):329-333. https://doi.org/10.1097/MBC.0000000000000575.
34. Hartmann J, Croteau SE. 2017 clinical trials update: innovations in hemophilia therapy. Am J Hematol. 2016;91(12):1252-1260. https://doi.org/10.1002/ajh.24543.
35. Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia a with inhibitors. N Engl J Med. 2017;377(9):809-818. https://doi.org/10.1056/NEJMoa1703068.
36. Young G, Sidonio RF, Liesner R, et al. HAVEN 2 updated analysis: multicenter, open-label, phase 3 study to evaluate efficacy, safety and pharmacokinetics of subcutaneous Administration of Emicizumab Prophylaxis in pediatric patients with hemophilia a with inhibitors. Blood. 2017;130(Suppl 1):85.
37. Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia a without inhibitors. N Engl J Med. 2018;379(9):811-822. https://doi.org/10.1056/NEJMoa1803550.
38. Al-Samkari H, Croteau SE. Shifting landscape of hemophilia therapy: implications for current clinical laboratory coagulation assays. Am J Hematol. 2018;93:1082-1090. https://doi.org/10.1002/ajh.25153.
39. Shima M, Hanabusa H, Taki M, et al. Long-term safety and efficacy of emicizumab in a phase 1/2 study in patients with hemophilia A with or without inhibitors. Blood Adv. 2017;1:1891-1899.
40. Knoebl P, Marco P, Baudo F, et al. Demographic and clinical data in acquired hemophilia a: results from the European acquired Haemophilia Registry (EACH2). J Thromb Haemost. 2012;10(4):622-631. https://doi.org/10.1111/j.1538-7836.2012.04654.x.
41. Collins PW, Hirsch S, Baglin TP, et al. Acquired hemophilia a in the United Kingdom: a 2-year national surveillance study by the United Kingdom Haemophilia Centre Doctors' organisation. Blood. 2007;109(5):1870-1877. https://doi.org/10.1182/blood-2006-06-029850.
42. Baudo F, Collins P, Huth-Kühne A, et al. Management of bleeding in acquired hemophilia a: results from the European acquired Haemophilia (EACH2) Registry. Blood. 2012;120(1):39-46. https://doi.org/10.1182/blood-2012-02-408930.
43. Anderson L, Quasim I, Steven M, et al. Interoperator and Intraoperator variability of whole blood coagulation assays: a comparison of Thromboelastography and rotational thromboelastometry. J Cardiothorac Vasc Anesth. 2014;28(6):1550-1557. https://doi.org/10.1053/j.jvca.2014.05.023.
44. Kitchen D, Kitchen S, Jennings I, Woods T, Walker I. Quality assurance and quality control of thrombelastography and rotational thromboelastometry: the UKNEQAS for blood coagulation experience. Semin Thromb Hemost. 2010;36(07):757-763. https://doi.org/10.1055/s-0030-1265292.