Blood coagulation tests in toxicological studies - Review of methods and their significance for drug safety assessment

Journal of Toxicological Sciences

Volumn 29, Issue 1, 2004, Pages 13-32

  Kurata, Masaaki ^a   Horii, Ikuo ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Blood coagulation; Fibrinolysis; Laboratory animals; Platelets; Toxicological study

Indexed keywords

ANTIVITAMIN K; BLOOD CLOTTING FACTOR; D DIMER; FIBRIN; FIBRINOGEN; PLASMIN; PLASMIN INHIBITOR; PLASMINOGEN; VITAMIN K GROUP; VON WILLEBRAND FACTOR;

ANALYTIC METHOD; BLEEDING TIME; BLOOD CLOTTING TEST; DRUG SAFETY; EXPERIMENTAL ANIMAL; FIBRINOLYSIS; IN VIVO STUDY; MEDICAL LITERATURE; NONHUMAN; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; REVIEW; RISK ASSESSMENT; SCREENING TEST; SPECIES; THROMBOCYTE ADHESION; THROMBOCYTE AGGREGATION; THROMBOCYTE DYSFUNCTION; THROMBOELASTOGRAPHY; TOXICITY TESTING;

ANIMALIA;

EID: 1642422357     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.29.13     Document Type: Review

References (91)

1. Aasen, A.O., Gallimore, M.J., Ohlsson, K. and Amundsen, E. (1978): Alterations of plasmin activity, plasminogen levels and activity of antiplasmins during endotoxin shock in dogs. Haemostasis, 7, 164-169.
2. Addonizio, V.P., Edmunds, L.H. and Colman, R.W. (1978): The function of monkey (M. mulatta) platelets compared to platelets of pig, sheep, and man. J. lab. Clin. Med., 91, 989-997.
3. Asakura, H., Suga, Y., Aoshima, K., Ontachi, Y., Mizutani, T., Kato, M., Saito, M., Morishita, E., Yamazaki, M., Takami, A., Miyamoto, K. and Nakao, S. (2002): Marked difference in pathophysiology between tissue factor- and lipopolysaccharide-induced disseminated intravascular coagulation models in rats. Crit. Care Med., 30, 161-164.
4. Blaisdell, F.S. and Dodds, W.J. (1977): Evaluation of two microhematocrit methods for quantitating plasma fibrinogen. J. Am. Vet. Med. Assoc., 171, 340-343.
5. Bloom, J.C. (1993): Principle of hematotoxicity: Laboratory assessment and interpretation of data. Toxicol. Pathol., 21, 130-134.
6. th ed. (Klaassen, C.D., ed.), pp. 389-417, McGraw-Hill, New York.
7. Born, G.V.R. (1962): Quantitative investigations into the aggregation of blood platelets. J. Physiol., 162, 67-68.
8. Brinkhous, K.M., Thomas, B.D., Ibrahim, S.A. and Read, M.S. (1977): Plasma levels of platelet aggregating factor/von Willebrand factor in various species. Thromb. Res., 11, 345-355.
9. Cardinal, D.C. and Flower, R.J. (1980): The electronic aggregometer: A novel device for assessing platelet behavior in blood. J. Pharmacol. Meth., 3, 135-158.
10. Clauss, V.A. (1957): Gerinnugsphysiologische schnellmethode zur bestimmung des fibrinogens. Acta Haemtol., 17, 237-246.
11. Clemmons, R.M. and Meyers, K.M. (1984): Acquisition and aggregation of canine blood platelets: Basic mechanisms of function and differences because of breed origin. Am. J. Vet. Res., 45, 137-144.
12. Cohen, M., Simmons, D.J. and Joist, J.H. (1978): Diurnal hemostatic changes in rats. Thromb. Res., 12, 965-971.
13. Cury, M.C., Lima, W.S., Guimaraes, M.P. and Carvalho, M.G. (2002): Hematological and coagulation profiles in dogs experimentally infected with Angiostrongylus vasorum. Vet. Pathol., 104, 139-149.
14. th ed. (Feldman, B.F., Zinkl, J.G. and Jain, N.C., eds.), pp. 544-548, Lippincott Williams and Wilkins, Philadelphia.
15. Dawicki, D.D., Agarwal, K.C. and Parks, R.E. Jr. (1985): Role of adenosine uptake and metabolism by blood cells in the antiplatelet actions of dipyridamole, dilazep and nitrobenzylthioinosine. Biochem. Pharmacol., 34, 3965-3972.
16. th ed. (Kaneko, J.J., Harvey, J.W. and Bruss, M.L., eds.), pp. 241-283, Academic Press, San Diego.
17. Dodds, W.J. (1978): Platelet function in animals: Species specificities. In Platelets: A Multidisciplinary Approach (DeGaetano, G. and Garattini, S., eds.), pp. 45-59, Raven Press, New York.
18. Dwyer, S.D. and Meyers, K.M. (1986): Rat platelet aggregation: Strain and stock variations. Thromb. Res., 42, 49-53.
19. Elg, M., Carlsson, S. and Gustafsson, D. (2001): Effects of agents, used to treat bleeding disorders, on bleeding time prolonged by a very high dose of a direct thrombin inhibitor in anesthesized rats and rabbits. Thromb. Res., 101, 159-170.
20. 2 and adenosine diphosphate in collagen-induced aggregation in man and the rat. Br. J. Pharmacol., 87, 109-115.
21. Faraday, N. (2002): Platelet, perioperative hemostasis, and anesthesia. Anesthesiology, 96, 1042-1043.
22. Feingold, H.M., Pivacek, L.E., Melaragno, A.J. and Valeri, C. (1986): Coagulation assays and platelet aggregation patterns in human, baboon, and canine blood. Am. J. Vet. Res., 47, 2197-2199.
23. Friberger, P., Knos, M., Gustravsson, S., Aurell, L. and Claeson, G. (1978): Methods for determination of plasmin, antiplasmin and plasminogen by means of substrate S-2251. Haemostasis, 7, 138-145.
24. Griffin, L.C., Tidmarsh, G.F., Bock, L.C., Toole, J.J. and Leung, L.K. (1993): In vivo anticoagulant properties of a novel nucleotide - based thrombion inhibitor and demonstration of regional anticoagulation in extracorporeal circuits. Blood, 81, 3271-3276.
25. Harauchi, T., Takano, K., Matsuura, M. and Yoshizaki, T. (1986): Liver and plasma levels of descarboxyprothrombin (PIVKA II) in vitamin K deficiency in rats. Japan. J. Pharmacol., 40, 491-499.
26. Hartert, H. (1951) Die thrombelastographie. Eine methods zur physikalischen analyse des blutgerinnungsvorganges. Z. Exper. Med., 117, 189-203.
27. Hayashi, M., Hamada, A., Okaya, Y., Wakitani, K. and Aisaka, K. (2001): Inhibitory effect of JTV-803, a new cyclic guanidine derivative, on factor Xa in vitro and in vivo. Eur. J. Pharmacol., 428, 163-168.
28. 2 receptor antagonist, on the secondary aggregation and ATP release of human platelets. Biol. Pharm. Bull., 20, 625-631.
29. Hwang, D.H. (1980): Aggregation and inhibition of rat platelets, and the information of endoperoxide metabolism. Prostagland. Med., 5, 163-173.
30. Iazbik, C., Couto, C.G., Gray, T.L. and Kociba, G. (2001): Effect of storage conditions on hemostatic parameters of canine plasma obtained for transfusion. Am. J. Vet. Res., 62, 734-735.
31. 2+-activated phospholipid-dependent myosin phosphorylation. J. Biol. Chem., 259, 14321-14323.
32. Inarrea, P., Gomez-Cambronero, J., Nieto, M. and Crespo, S. (1984): Characteristics of the binding of platelet-activating factor to platelets of different animal species. Eur. J. Pharmacol., 105, 309-315.
33. Ingram, G.I.C. and Hills, M. (1976): The prothrombin time test: Effect of varying citrate concentration. Throm. Haemost., 36, 230-236.
34. Ishii, F., Iizuka, B., Nakanishi, T., Nagasako, K. and Hayashi, N. (1997): Vitamin K deficiency syndrome caused by antituberculous agents. Nihon Shyokaki-byo Gakkai Zasshi, 94, 389-397.
35. Johnson, G.J., Leis, L.A., Rao, G.H.R. and White, J. G. (1979): Arachidonate-induced platelet aggregation in dog. Thromb. Res., 14, 147-157.
36. Johnson, G.J., Leis, L.A. and King, R.A. (1991): Thromboxane responsiveness of dog platelets is inherited as an autosomal recessive trait. Thromb. Haemostat., 65, 578-580.
37. Johnstone, I.B. (1999): Plasma von Willebrand factor - collagen binding activity in normal dogs and in dogs with von Willebrand's disease. J. Vet. Diagn. Invest., 11, 308-313.
38. th ed. (Feldman, B.F., Zinkl, J.G. and Jain, N.C., eds.), pp. 538-543, Lippincott Williams and Wilkins, Philadelphia.
39. 1. Am. J. Physiol., 232, H12-17.
40. Kageyama, S., Matsushita, J. and Yamamoto, H. (2002): Effect of a humanized monoclonal antibody to von Willebrand factor in a canine model of coronary arterial thrombosis. Eur. J. Pharmacol., 443, 143-149.
41. Kaku, S., Kawasaki, T., Hisamichi, N., Sakai, Y., Taniuchi, Y., Inagaki, O., Yano, S., Suzuki, K., Terazaki, C., Masuho, Y., Satoh, N., Takenaka, T., Yanagi, K. and Ohshima, N. (1996): Antiplatelet and antithrombotic effects of YM337, the Fab fragment of a humanized anti-GPIIb/IIIa monoclonal antibody in monkeys. Thromb. Haemostasis., 75, 679-684.
42. Karges, H.E., Funk, K.A. and Ronneberger, H. (1994): Activity of coagulation and fibrinolysis parameters in animals. Arzneim.-Forsch./Drug Res., 44, 793-797.
43. Kase, F. (1978): The effect of homo- and heterologous thromboplastins on plasmas of man, seven mammalian and two avian species: A comparative study. Comp. Biochem. Physiol., 61A, 65-68.
44. Koepke, J.A., Rodgers, J.L. and Olivier, M.J. (1975): Pre-instrumental variables in coagulation testing. Am. J. Clin. Pathol., 64, 591-596.
45. Kurata, M., Ishizuka, N., Matsuzawa, M., Haruta, K. and Takeda, K. (1995): A comparative study of whole-blood platelet aggregation in laboratory animals: Its species differences and comparison with turbidimetric method. Comp. Biochem. Physiol., 112C, 359-365.
46. Kurata, M., Tanaka, K. and Usami, M. (1997): Different roles of endothelium-derived substances on inhibiting platelet aggregation in whole blood. Gen. Pharmacol., 28, 671-673.
47. Kurata, M., Noguchi, N., Kasuga, Y., Sugimoto, T., Tanaka, K. and Hasegawa, T. (1998): Prolongation of PT and APTT under excessive anticoagulant in plasma from rats and dogs. J. Toxicol. Sci., 23, 149-153.
48. Lanevschi, A., Kramer, J.W., Greene, S.A. and Meyers, K.M. (1996): Evaluation of chromogenic substrate assays for fibrinolytic analytes in dogs. Am. J. Vet. Res., 57, 1124-1130.
49. Laudes, I.J., Chu, J.C., Sikranth, S., Huber-Lang, M., Guo, R.F., Riedemann, N., Sarma, J.V., Schmaier, A.H. and Ward, P.A. (2002): Anti-C5a ameliorates coagulation/fibrinolytc protein changes in a rat model of sepsis. Am. J. Pathol., 160, 1867-1875.
50. Leis, L.A., Rosborough, T.K., Johnson, G.S. and Johnson, G.J. (1980): Ristocetin-induced aggregation of canine platelets. Thromb. Res., 19, 309-316.
51. Lewis, E.J., Bishop, J. and Cashin, C.H. (1989): Automated quantification of rat plasma acute phase reactants in experimental inflammation. J. Pharmac. Meth., 21, 183-194.
52. Macmillan, D.C. and Sim, A.K. (1970): A comparative study of platelet aggregation in man and laboratory animals. Thromb. Diathes. Haemorrh., 24, 385-394.
53. th ed. (Hardman, J.G., Limbird, L.E. and Gilman, A.G., eds.), pp. 1519-1538, McGraw-Hill, New York.
54. Mallett, S.V. and Cox, D.J.A. (1992): Thrombelastography., Br. J. Anaesth., 69, 307-313.
55. Matsuura, M., Satoh, S., Takano, K., Harauchi, T., Yoshizaki, T., Kobayashi, F., Matsubara, T. and Uchida, K. (1988): Vitamin K-reversible hypothrombinemia in rats. I. Sex differences in development of hypoprombinemia and the effects of beta-lactam antibiotics. Japan. J. Pharmacol., 46, 303-310.
56. Millar, H.R., Simpson, H.G. and Stalker, A.L. (1971): An evaluation of the heat precipitation method for plasma fibrinogen estimation. J. Clin. Path., 24, 827-830.
57. th ed. (Feldman, B.F., Zinkl, J.G. and Jain, N.C., eds.), pp. 519-525, Lippincott Williams and Wilkins, Philadelphia.
58. Mischke, R. (2001): Optimization of coagulometric tests that incorporate human plasma for determination of coagulation factor activities in canine plasma. Am. J. Vet. Res., 64, 625-629.
59. Moser, J., Meyers, K.M., Russon, R.H. and Reeves, J.J. (1998): Plasma von Willebrand factor changes during various reproductive cycle stages in mixed-breed dogs with normal von Willebrand factor and in Doberman pinschers with type-I von Willerband's disease. Am. J. Vet. Res., 59, 111-118.
60. Mount, M., Kim, B.U. and Kass, P.H. (2003): Use of a test for proteins induced by vitamin K absence or antagonism in diagnosis of anticoagulant poisoning in dogs: 325 cases (1987-1997). J. Am. Vet. Med. Assoc., 222, 194-198.
61. Mussoni, L., Raczka, E., Chmielewska, J., Donati, M. B. and Latollo, Z.S. (1979): Plasminogen assay in rabbit, rat and mouse plasma using the chromogenic substrate S-2251. Thromb. Res., 15, 341-349.
62. Nelsestuen, G.L., Shah, A.M. and Harvey, S.B. (2000): Vitamin K-dependent proteins. Vitam. Horm., 58, 355-389.
63. Newsholme, S.J., Thudium, D.T., Gossett, K.A., Watson, E.S. and Schwartz, L.W. (2000): Evaluation of plasma von Willebrand factor as a biomarker for acute arterial damage in rats. Toxicol. Pathol., 28, 688-693.
64. Nobukata, H., Ishikawa, T., Obata, M. and Shibutani, Y. (2000): Age-related changes in coagulation, fibrinolysis, and platelet aggregation in male WBN/Kob rats. Thromb. Res., 98, 507-516.
65. Nolte, I., Niemann, C., Bowry, S.K., Failing, K. and Muller-Berghaus, G. (1997): A method for measuring capillary bleeding time in non-anaesthetized dogs: Prolongation of the bleeding time by acetylsalicylic acid. J. Vet. Med., 44, 625-628.
66. O'Brien, S.R., Sellers, T.S. and Meyer, D.J. (1995): Artifactual prolongation of the activated partial thromboplastin time associated with hemoconcentration in dogs. J. Vet. Int. Med., 3, 169-170.
67. Otto, C.M., Rieser, T.M., Brooks, M.B. and Russell, M.W. (2000): Evidence of hypercoagulability in dogs with parvoviral enteritis. J. Am. Vet. Med. Assoc., 217, 1500-1504.
68. Owens, M.R., Cimino, C.D. and Donnelly, J. (1986): Measurements of rat plasma coagulation proteins during prolonged exposure to diethylstilbesterol. Thromb. Res., 42, 343-354.
69. th ed. (Beutler, E., Lichtman, M.A., Coller, B.S., Kipps, T.J. and Seligsohn, U., eds.), pp. 1357-1408, McGraw-Hill, New York.
70. Proctor, R.R. and Rapaport, S.I. (1961): The partial thromboplastin time with kaolin. Am. J. Clin. Pathol., 36, 212-219.
71. Quick, A.J., Stanley-Brown, M. and Bancroft, F.W. (1935): A study of the coagulation defect in hemophilia and in jaundice. Am. J. Med. Sci., 190, 501-511.
72. Rao, L.V., Okorodudu, A.O., Petersen, J.R. and Elghetany, M.T. (2000): Stability of prothrombin time and activated partial thromboplastin time tests under different storage conditions. Clin Chimica Acta, 300, 13-21.
73. Ravanat, C., Freund, M., Dol, F., Cadroy, Y., Roussi, J., Incardona, F., Maffrand, J.P., Boneu, B., Drouet, L., Legrand, C., Herbert, J.M. and Cazenave, J.P. (1995): Cross-reactivity of human molecular markers for detection of prethrombotic states in various animal species. Blood Coagul. Fibronolysis, 6, 446-455.
74. Ribau, J.C.O., Hatton, M.W.C. and Richardson, M. (1998): Changes in the aortic endothelium and plasma von Willebrand factor levels during the onset and progression of insulin-dependent diabetes in BB rats. Atherosclerosis, 139, 291-299.
75. th ed. (Beutler, E., Lichtman, M.A., Coller, B.S., Kipps, T.J. and Seligsohn, U., eds.), pp. 1409-1433, McGraw-Hill, New York.
76. th ed. (Feldman, B.F., Zinkl, J.G. and Jain, N.C., eds.), pp. 532-537, Lippincott Williams and Wilkins, Philadelphia.
77. Salzman, E.W. (1963): Measurement of platelet adhesiveness. J. Lab. Clin. Med., 62, 724-735.
78. Scott-Moncrieff, J.C., Treadwell, N.G., McCulloughn, S.M. and Brooks, M.B. (2001): Hemostatic abnormality in dogs with primary immune-mediated hemolytic anemia. J. Am. Anim. Hosp. Assoc., 37, 220-227.
79. th ed. (Beutler, E., Lichtman, M.A., Coller, B.S., Kipps, T.J. and Seligsohn, U., eds.), pp. 1471-1477, McGraw-Hill, New York.
80. Silveira, V.L.F. and Limoas, E.A. (1990): Effect of bacterial endotoxin on plasma concentration of haptoglobin and fibrinogen in rats treated with metopyrone. Agents and Actions., 31, 143-147.
81. Soloviev, M.V., Okazaki, Y. and Harasaki, H. (1999): Whole blood platelet aggregation in humans and animals: A comparative study. J. Surg. Res., 82, 180-187.
82. Stokol, T., Brooks, M.B., Erb, H.N. and Mauldin, G.E. (2000): D-Dimer concentration in healthy dogs and dogs with disseminated intravascular coagulation. Am. J. Vet. Res., 61, 393-398.
83. Tabata, H., Nakamura, S. and Matsuzawa, T. (1995): Some species differences in the false prolongation of prothrombin times and activated partial thromboplastin times in toxicology. Comp. Haematol. Int., 5, 140-144.
84. Torres Duarte, A.P., Dong, Q.S., Young, J., Abi-Younes, S. and Myers, A.K. (1995): Inhibition of platelet aggregation in whole blood by alcohol. Thromb. Res., 78, 107-115.
85. Uchida, K., Nomura, Y., Takase, H., Harauchi, T., Yoshizaki, T. and Nakao, H. (1986): Effect of vitamin K-deficient diets and fasting on blood coagulation factors in conventional and germ-free rats. Japan. J. Pharmacol., 40, 115-122.
86. Van Ness, K., Chobaz-Peclat, V., Castellucci, M., So, A. and Busso, N. (2002): Plasminogen activator inhibitor type-1 deficiency attenuates murine antigen-induced arthritis. Rheumatology, 41, 136-141.
87. Weiner, E.J., Stucchi, A.F., Foxall, T.L., Shwaery, G.T., Yoganathan, S. and Nicolosi, R. J. (1994): The effects of doxazosin on platelet aggregation, platelet adhesion and blood coagulation in cynomolgus monkeys. Artherosclerosis, 107, 35-44.
88. Wohl, R.C., Sinio, L., Summaria, L. and Robbins, K.C. (1983): Comparative activation kinetics of mammalian plasminogens. Biochim. Biophys. Acta, 745, 20-31.
89. Yasunaga, K. (1976): Platelet adhesion test, glass beads methods. Rinsgyo-Kensa, 20, 135-140, (in Japanese).
90. th annual meeting), 26, 221.
91. th annual meeting), 27, 373.