College of American pathologists conference XXXI on laboratory monitoring of anticoagulant therapy: Laboratory monitoring of oral anticoagulant therapy

Archives of Pathology and Laboratory Medicine

Volumn 122, Issue 9, 1998, Pages 768-781

  Fairweather, Robert B ^a   Ansell, Jack ^f   Van Den Besselaar, Anton M H P ^f   Brandt, John T ^b   Bussey, Henry I ^c   Poller, Leon ^f   Triplett, Douglas A ^d   White, Richard H ^e  

^a DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^d BALL MEMORIAL HOSPITAL   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; HEPARIN DERIVATIVE;

ANTICOAGULANT THERAPY; CONFERENCE PAPER; DATA ANALYSIS; DRUG MONITORING; GOOD LABORATORY PRACTICE; HOME MONITORING; HUMAN; MEDICAL LITERATURE; MEDICAL SOCIETY; MEDICAL SPECIALIST; PRACTICE GUIDELINE; PROTHROMBIN TIME; THROMBOPLASTIN TIME;

EID: 0031662868     PISSN: 00039985     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (110)

1. European Committee for Clinical Laboratory Standards (ECCLS). Standard for Specimen Collection: Part 1. Blood Containers. Vol 3.1. Coventry, West Midlands, United Kingdom: University of Warwick; 1983.
2. European Committee for Clinical Laboratory Standards (ECCLS). Part 2. Blood Specimen by Venipuncture. Vol 4.1. Coventry, West Midlands, United Kingdom: University of Warwick; 1987.
3. Collection, Transport and Preparation of Blood Specimens for Coagulation Testing and Performance of Coagulation Assays: Approved Guideline. Villanova, Pa: National Committee for Clinical Laboratory Standards; 1991. NCCLS document H21-A3.
4. Duncan EM, Casey CR, Duncan BM, Lloyd JV. Effect of concentration of trisodium citrate anticoagulant on calculation of the international normalized ratio and the international sensitivity index of thromboplastin. Thromb Haemost 1994;72:84-88.
5. Chantarangkul V, Tripodi A, Clerici M, Negri B, Braga M. Influence of citrate concentration on the international sensitivity index of five thromboplastins. Thromb Haemost. 1995;73:1237. Abstract 1287.
6. Adcock DM, Kressen DC, Marlar RA. Effect of 3.2% vs. 3.8% sodium citrate on routine coagulation testing. Am J Clin Pathol. 1997;107:105-110.
7. Dwyre AL, Giles AR, Key LA, Butler JR, Beck LR, Callahan JB. The effects of sodium citrate anticoagulant concentration, storage on or off cellular matrix, and specimen age on prothrombin time INR using a low ISI (1.06) rabbit brain thromboplastin. Thromb Haemost. 1995;73:1237. Abstract 1290.
8. WHO Expert Committee on Biological Standardisation. 33rd Report. World Health Organ Tech Rep Ser. 1983;687:81-105.
9. Koepke JA, Rodgers JL, Ollivier J. Pre-instrumental variables in coagulation testing. Am J Clin Pathol. 1975;64:591-596.
10. van den Besselaar AMHP, Halem-Visser LP, Loeliger EA. The use of evacuated tubes for blood collection in oral anticoagulant control. Thromb Haemost 1983;50:676-677.
11. Raskob GE, Durica SS, Owen WL, Comp PC. Monitoring low-dose warfarin therapy by a central laboratory and implications for clinical trials and patient care: the Coumadin Aspirin Reinfarction (CARS) Pilot Study Group. Am J Cardiol. 1996;78:1074-1076.
12. Baglin T, Luddington R. Reliability of delayed INR determination: implications for decentralized anticoagulant care with off-site blood sampling. Br J Haematol. 1997;96:431-434.
13. Hirsh J, Dalen JE, Deykin D, Poller L, Bussey H. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 1995;108(suppl):231S-246S.
14. Taberner DA, Poller L, Thomson JM, Darby KV. Effect of international sensitivity index (ISI) of thromboplastins on precision of international normalized ratios (INR). J Clin Pathol. 1989;42:92-96.
15. Moriarty HT Lam-Po-Tang PR, Anastas N. Comparison of thromboplastins using the ISI and INR system. Pathology. 1990;22:71.
16. van den Besselaar AMHP. Precision and accuracy of the international normalized ratio in oral anticoagulant control. Haemostasis. 1996;26(suppl 4):248-265.
17. van den Besselaar AMHP, Evatt BL, Brogan DR, Triplett DA. Proficiency testing and standardization of prothrombin time: effect of thromboplastin, instrumentation, and plasma. Am J Clin Pathol. 1984;82:688-699.
18. Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The value of plasma calibrants in correcting coagulometer effects on international normalized ratios -an international multicenter study. Am J Clin Pathol. 1995;103:358-365.
19. Poller L, Hirsh J. Laboratory monitoring of anticoagulants. In: Poller L, Hirsh J, eds. Oral Anticoagulants. London, England: Arnold; 1996:49-64.
20. Kitchen S, Walker ID, Woods TAL, Preston FE. Thromboplastin related differences in the determination of international normalized ratio: a cause for concern? Thromb Haemost. 1994;72:426-429.
21. Brien WF, Crawford L, Wood DE. Discrepant results in INR testing. Thromb Haemost. 1994;72:986-987.
22. Harrison L, Johnston M, Massicotte MP, et al. Comparison of 5 mg and 10 mg loading dose in initiation of warfarin therapy. Ann Intern Med. 1997;126: 133-136.
23. Brophy MT, Fiore LD, Lau J, Goodwin R, Lopez A, Deykin D. Comparison of a standard and a sensitive thromboplastin in monitoring low intensity oral anticoagulant therapy. Am J Clin Pathol. 1994;102:134-137.
24. Barcellona D, Biondi G, Vannini ML, Marongiu F. Comparison between recombinant and rabbit thromboplastin in the management of patients on oral anticoagulant therapy. Thromb Haemost. 1996;75:488-490.
25. Minutes, ISTH/SCC Subcommittee on Control of Anticoagulation, Florence, Italy; June 7, 1997. WHO Expert Committee on Biological Standardisation. 46th Report. World Health Organ Tech Rep Ser. 1998;872:64-69.
26. Poggio M, van den Besselaar AMHP, van de velde EA, Bertina RM. The effect of some instruments for prothrombin time testing on the International Sensitivity Index (ISI) of two rabbit tissue thromboplastin reagents. Thromb Haemost 1988;62:868-874.
27. D'Angelo A, Seveso MP, D'Angelo SV, Gilardoni F, Macagni A, Manotti C. Comparison of two automated coagulometers and the manual tilt tube method for the determination of prothrombin time. Am J Clin Pathol. 1989;92:321-328.
28. Poller L, Thomson JM, Taberner DA. Effect of automation on the prothrombin time test in NEQAS surveys. J Clin Pathol. 1989;42:97-100.
29. van Rijn JLML, Schmidt NA, Rutten W. Correction of instrument and reagent based differences in determination of the international normalised ratio (INR) for monitoring anticoagulant therapy. Clin Chem. 1989;355:840-843.
30. Ray MJ, Smith IR. The dependence of the International Sensitivity Index on the coagulometer used to perform the prothrombin time. Thromb Haemost. 1990;63:424-429.
31. Clarke K, Taberner DA, Thomson JM, Morris JA, Poller L. Assessment of value of calibrated lyophilized plasmas to determine International Sensitivity Index for coagulometers. J Clin Pathol. 1992;45:58-60.
32. Poller L, Thomson JM, Taberner DA, Clarke DK. The correction of coagulometer effects on international normalized ratios: a multicentre evaluation. Br J Haematol. 1994;86:112-117.
33. Cunningham MT, Johnson GF, Pennel BJ, Olsen JD. The reliability of manufacturer-determined instrument-specific international sensitivity index values for calculating the international normalized ratio. Am J Clin Pathol. 1994;102:128-133.
34. Houghton D, Barrowcliffe T, van den Besselaar AMHP, Jespersen J, Tripodi A, Poller L. European Concerted Action on Anticoagulation (ECAA): ECAA field studies of lyophilized plasmas in local prothrombin time (PT) system ISI calibration. Thromb Haemost. 1997;77(suppl):179. Abstract OC-724.
35. Poller L, Barrowcliffe TW, van den Besselaar AMHP, Tripodi A, Houghton D. European Concerted Action on Anticoagulation (ECAA): an evaluation of a set of lyophilized normal plasmas to establish the normal prothrombin time for coagulometer systems. Thromb Haemost. 1998;79:122-128.
36. Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. European Concerted Action on Anticoagulation: a simplified statistical method for local INR using linear regression. Br J Haematol. 1997;98:640-647.
37. Miale JB, LaFond DJ. Prothrombin time standardisation. Am J Clin Pathol. 1967;47:40-46.
38. Miale JB, LaFond DJ. Prothrombin time standardisation. Proposal of the Standards Committee, College of American Pathologists, Sub-Committee on Coagulation Reagents. Am J Clin Pathol. 1969;52:154-160.
39. Miale JB, Kent JW. Performance characteristic of reference thromboplastins. Am J Clin Pathol. 1973;40:453-457.
40. Houbouyan IL, Goguel AF. Procedure of reference calibrated plasmas for prothrombin time standardisation. Thromb Haemost. 1993;69:663. Abstract.
41. Stevenson KJ, Craig S, Dufty JMK, Taberner DA. System ISI calibration: a universally applicable scheme is possible only when coumarin plasma calibrants are used. Br J Haematol. 1997;96:435-441.
42. Houbouyan LI, Goguel AF. Long-term French experience in INR standardization by a procedure using plasma calibrants. Am J Clin Pathol. 1997;108:83-89.
43. Tripodi A, Chantarangkul V, Manotti C, et al. Simplified procedure for thromboplastin calibration - the usefulness of lyophilized plasmas assessed in a collaborative study. Thromb Haemost. 1996;75:309-312.
44. van den Besselaar AMHP. Comparison of lyophilized plasmas with fresh plasmas for calibration of thromboplastin reagents in oral anticoagulant control. Br J Haematol. 1996;93:437-444.
45. Tripodi A, Chantarangkul V, Akkawat B, Clerici M, Manucci PM. A partial factor V deficiency in anticoagulated lyophilized plasmas has been identified as a cause of the INR discrepancy in the External Quality Assessment Scheme. Thromb Res. 1995;79:283-292.
46. van den Besselaar AMHP. Field study for lyophilized plasmas for local prothrombin time calibration in the Netherlands. J Clin Pathol. 1997;50:371-374.
47. van den Besselaar AMHP. The use of lyophilized calibration plasmas and control blood for INR calculation on external quality control of the prothrombin time. Am J Clin Pathol. 1993;102:123-127.
48. Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. A comparison of lyophilized artificially depleted plasmas and lyophilized plasmas from patients receiving warfarin in correction for coagulometer effects on international normalized ratios. Am J Clin Pathol. 1995;103:366-371.
49. Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. Minimum lyophilized plasma requirement for ISI calibration. Am J Clin Pathol. 1998;109:196-204.
50. Hubbard AR, Margetts SML, Barrowcliffe TW. International normalized ratio determination using calibrated reference plasmas. Br J Haematol. 1997;98: 74-78.
51. Lutomski DM, Djaric PE, Draeger RW. Warfarin therapy: the effect of heparin on prothrombin times. Arch Int Med. 1987;147:432-433.
52. Schultz NJ, Slaker RA, Rosborough TK. The influence of heparin on the prothrombin time. Pharmacotherapy. 1991;11:312-316.
53. Sawyer WT, Raasch RH. Effect of heparin on prothrombin time. Clin Pharm. 1984;3:192-194.
54. Solomon HM, Randall JR, Simmons VL. Heparin-induced increase in the INR. Am J Clin Pathol. 1995;103:735-739.
55. College of American Pathologists. Limited Coagulation Survey, 1997 Set CG1-A. College of American Pathologists: Chicago, Ill.
56. Thompson AR, Counts RB. Removal of heparin and protamine from plasma. J Lab Clin Med. 1976;88:922-929.
57. van den Besselaar AMHP, Meeuwisse-Braun J. Enzymatic elimination of heparin from plasma for activated partial thromboplastin time and prothrombin time testing. Blood Coagul Fibrinolysis. 1993;4:635-638.
58. Wenz B, Burns ER. Rapid removal of heparin from plasma by affinity filtration. Am J Clin Pathol. 1991;96:385-390.
59. Johnston M, Harrison L, Moffat K, Willan A, Hirsh J. Reliability of the international normalized ratio for monitoring the induction phase of warfarin: comparison with the prothrombin time ratio. J Lab Clin Med. 1996;128:214-217.
60. Kovacs MJ, Wong A, MacKinnon K, et al. Assessment of the validity of the INR system for patients with liver impairment. Thromb Haemost. 1994;71:727-730.
61. Ts'ao C, Swedlund J, Neofotistos D. Implications of use of low international sensitivity index thromboplastins in prothrombin time testing. Arch Pathol Lab Med. 1994;118:1183-1187.
62. Koepke JA. Is the international normalized ratio also 'valid' for prothrombin times measured in patients not receiving oral anticoagulants? Arch Pathol Lab Med. 1994;118:1181-1182. Editorial.
63. Tan G, Cohen H, Taylor F, Gabbay J. Audit of start of anticoagulation treatment in inpatients. J Clin Pathol. 1993;46:67-71.
64. Howard MR, Mulligan DW. Frequency of attendance at anticoagulant clinics: a prospective study. Br Med J. 1988;296:898-899. Letter.
65. Rospond RM, Quandt CM, Clark GM, Bussey HI. Evaluation of factors associated with stability of anticoagulation therapy. Pharmacotherapy. 1989;9: 207-213.
66. Horstkotte D, Piper C, Wiemer M, Schulte HD, Schultheiss HP. Improvement of prognosis by home prothrombin estimation in patients with life-long anticoagulant therapy, Eur Heart J. 1996;17(suppl):230.
67. 1 content. Thromb Haemost. 1997;77:504-509.
68. Fihn SD, McDonell MB, Vermes D, et al. A computerized intervention to improve timing of outpatient follow-up: a multicenter randomized trial in patients treated with warfarin. J Gen Int Med. 1994;9:131-139.
69. Brandt JT, Triplett DA, Alving B, Scharrer I. Criteria for the diagnosis of lupus anticoagulants: an update on behalf of the Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies of the SSC of the ISTH. Thromb Haemost 1995;74:1185-1190.
70. Lee MT, Nardi MA, Hadzi-Nesic J, Karpatkin M. Transient hemorrhagic diathesis associated with an inhibitor of prothrombin with lupus anticoagulant in a 11/2-year-old girl: report of a case and review of the literature. J Hematol. 1996; 5:307-314.
71. Moll S, Ortel TL. Monitoring warfarin therapy in patients with lupus anticoagulants. Ann Intern Med. 1997;127:177-185.
72. Della Valle P, Crippa L, Safa O, et al. Potential failure of the international normalized ratio (INR) system in the monitoring of oral anticoagulation in patients with lupus anticoagulants. Ann Med Interne (Paris). 1996;147(suppl):10-14.
73. Low J, Joseph J, Concannon A. INR discrepancies with a recombinant thromboplastin in two patients with the antiphospholipid syndrome. Thromb Haemost. 1997;77(suppl):701. Abstract PS-2861.
74. Lawrie AS, Purdy G, Mackie IJ, Machin SJ. Monitoring of oral anticoagulant therapy in lupus anticoagulant positive patients with the antiphospholipid syndrome. Br J Haematol. 1997;98:887-892.
75. Rosove MH, Brewer PM. Antiphospholipid thrombosis; clinical course after the first thrombotic event in 70 patients. Ann Intern Med. 1992;117:303-308.
76. Khamashta ML, Cuadrado MJ, Mujic F, Taub NA, Hunt BJ, Hughes GR. The management of thrombosis in the antiphospholipid-antibody syndrome. N Engl J Med. 1995;332:993-997.
77. Rapaport SI, Le DT. Thrombosis in the antiphospholipid antibody syndrome. N Engl J Med. 1995;333:665. Letter.
78. Le DT, Weibert RT, Sevilla BK, Donnelly KJ, Rapaport SI. The international normalized ratio (INR) for monitoring warfarin therapy: reliability and relation to other monitoring methods. Ann Intern Med. 1994;120:552-558.
79. Haraldsson HM, Onundarson PT, Einarsdottir KA, et al. Performance of prothrombin-proconvertin time as a monitoring test of oral anticoagulation therapy. Am J Clin Pathol. 1997;107:672-680.
80. Lind SE, Callas PW, Golden EA, loyner KA, Ortel TL. Plasma levels of factors II, VII, and X and their relationship to the international normalized ratio during chronic warfarin therapy. Blood Coagul Fibrinolysis. 1997;8:48-53.
81. Kornbert A, Francis DW, Pellegrini VD Jr, Bagriel KR, Marder VJ. Comparison of native prothrombin antigen with the prothrombin time for monitoring oral anticoagulant prophylaxis. Circulation. 1993;88:454-460.
82. Furie B, Diuguid CF, Jacobs M, Diuguid DL, Furie BC. Randomized prospective trial comparing the native prothrombin antigen with the prothrombin time for monitoring oral anticoagulant therapy. Blood. 1990;75:344-349.
83. Millenson MM, Bauer KA, Kistler JP, Barzegar S, Tulin L, Rosenberg R. Monitoring "mini-intensity" anticoagulation with warfarin: comparison of the prothrombin time using a sensitive thromboplastin with prothrombin fragment F 1+2 levels. Blood. 1992;79:2034-2038.
84. Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet. 1995;346:1085-1087.
85. Method Comparison and Bias Estimation Using Patient Samples. NCCLS Approved Guideline. Villanova, Pa: National Committee for Clinical Laboratory Standards; December 1995. EP9-A, vol 15, No. 17.
86. British Standards Institution. Precision of Test Methods, Part 1: Guide for the Determination of Repeatability and Reproducibility for a Standard Test Method. London, England: British Standards Institution; 1979. BS 5497.
87. Kaatz SS, White RH, Hill J, Mascha E, Humphries JE, Becker DM. Accuracy of laboratory and portable monitor INR determinations. Arch Intern Med. 1995;155:1861-1867.
88. Lucas FV, Duncan A, Jay R, et al. A novel whole blood capillary technique for measuring the prothrombin time. Am J Clin Pathol. 1987;88:442-446.
89. Belsey RE, Fischer PM, Baer DM. An evaluation of a whole blood prothrombin analyzer designed for use by individuals without formal laboratory training. J Fam Pract. 1991;33:266-271.
90. McCurdy SA, White RH. Accuracy and precision of a portable anticoagulation monitor in a clinical setting. Arch Intern Med. 1992;152:589-592.
91. Becker DM, Humphries JE, Walker FB, et al. Standardizing the prothrombin time: calibrating coagulation instruments as well as thromboplastin. Arch Pathol Lab Med. 1993;117:602-605.
92. Tripodi A, Arbini AA, Chantarangkul V, Bettega D, Mannucci PM. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the INR? Thromb Haemost. 1993;70:921-924.
93. Bussey HI, Chiquette E, Bianco TM, et al. A statistical and clinical evaluation of fingerstick and routine laboratory prothrombin time measurements. Pharmacotherapy. 1997;17:861-866.
94. Oberhardt BJ, Dermott SC, Taylor M, Alkadi ZY, Abruzzini AF, Gresalfi NJ. Dry reagent technology for rapid, convenient measurement of blood coagulation and fibrinolysis. Clin Chem. 1991;37:520-526.
95. Rose VL, Dermott SC, Murray BF. Decentralized testing for prothrombin time and activated partial thromboplastin time using a dry chemistry portable analyzer. Arch Pathol Lab Med. 1993;117:611-617.
96. Tripodi A, Clerici M, Negri B, Chantarangkul V, Mannucci PM. ISI determination for a new, very sensitive point-of-care testing device to monitor oral anticoagulant therapy: assessment of adequacy to the recommended WHO model. Blood. 1995;86(suppl):890a. Abstract.
97. Ansell J, Becker D, Andrew M, et al. Accurate and precise prothrombin time measurement in a multicenter anticoagulation trial employing patient self-testing. Blood. 1995;86(suppl):864a. Abstract.
98. Ansell J, Becker D, Andrew M, et al. Anticoagulation monitoring: accurate results with patient self-testing in a multicenter clinical trial. J Am Coll Cardiol. 1996;27(suppl):317A. Abstract.
99. Leaning KE, Ansell JE. Advances in the monitoring of oral anticoagulation: point of care testing, patient self monitoring and patient self management. J Throm Thrombolysis. 1996;3:377-383.
100. Kutner M, Nixon G, Silverstone F. Physicians' attitudes toward oral anticoagulants and antiplatelet agents for stroke prevention in elderly patients with atrial fibrillation. Arch Intern Med. 1991;151:1950-1953.
101. McCrory DC, Matchar DB, Samsa G, Sanders LL, Pritchett ELC. Physician attitudes about anticoagulation for nonvalvular atrial fibrillation in the elderly. Arch Intern Med. 1995;155:277-281.
102. Ansell JE, Hughes R. Evolving models of warfarin management: anticoagulation clinics, patient self-monitoring, and patient self-management. Am Heart J. 1996;132:1095-1100.
103. Levine MN, Raskob G, Landefeld S, Hirsh J. Hemorrhagic complications of anticoagulant treatment. Chest. 1995;108(suppl):276S-290S.
104. White RH, McCurdy SA, von Marensdorff H, Woodruff DE, Leftgoff L. Home prothrombin time monitoring after initiation of warfarin therapy. Ann Intern Med. 1989;111:730-737.
105. Anderson D, Harrison L, Hirsh J. Evaluation of a portable prothrombin time monitor for home use by patients who require long-term oral anticoagulant therapy. Arch Intern Med. 1993;153:1441-1447.
106. Erdman S, Vidne B, Levy MJ. A self-control method for long-term anticoagulation therapy. J Cardiovasc Surg. 1974;15:454-457.
107. Ansell J, Holden A, Knapic N. Patient self-management of oral anticoagulation guided by capillary fingerstick whole blood prothrombin times. Arch Intern Med. 1989;149:2509-2511.
108. Ansell J, Patel N, Ostrovsky D, Nozzolillo E, Peterson AM, Fish L. Long-term patient self-management of oral anticoagulation. Arch Intern Med. 1995; 155:2185-2189.
109. Bernardo A. Experience with patient self-management of oral anticoagulation. J Thromb Thrombolysis. 1996;2:321-325.
110. Piper C, Horstkotte D, Wiemer W, Schulte HD, Schultheiss HP. Optimization of oral anticoagulation following valve replacement: results of a prospective randomized study. Eur Heart J. 1996;17(suppl):230.