Thromb Haemost 1979; 42(04): 1073-1114
DOI: 10.1055/s-0038-1657004
Original Article
Schattauer GmbH Stuttgart

Prothrombin Time Standardization: Report of the Expert Panel on Oral Anticoagulant Control

The International Committee on Thrombosis and Haemostasis The International Committee for Standardization in Hematology
Further Information

Publication History

Publication Date:
23 August 2018 (online)

Summary

In collaborative experiments in 199 laboratories, nine commercial thromboplastins, four thromboplastins held by the National Institute for Biological Standards and Control (NIBS & C), London and the British Comparative Thromboplastin were tested on fresh normal and coumarin plasmas, and on three series of freeze-dried plasmas. One of these was made from coumarin plasmas and the other two were prepared from normal plasmas; in each series, one plasma was normal and the other two represented different degrees of coumarin defect.

Each thromboplastin was calibrated against NIBS&C rabbit brain 70/178, from the slope of the line joining the origin to the point of intersection of the mean ratios of coumarin/normal prothrombin times when the ratios obtained with the two thromboplastins on the same fresh plasmas were plotted against each other. From previous evidence, the slopes were calculated which would have been obtained against the NIBS&C “research standard” thromboplastin 67/40, and termed the “calibration constant” of each thromboplastin. Values obtained from the freeze-dried coumarin plasmas gave generally similar results to those from fresh plasmas for all thromboplastins, whereas values from the artificial plasmas agreed with those from fresh plasmas only when similar thromboplastins were being compared.

Taking into account the slopes of the calibration lines and the variation between laboratories, precision in obtaining a patient’s prothrombin time was similar for all thromboplastins.

 
  • References

  • 1 Alderson MR, Poller L, Thomson JM. 1970; Validity of the British system for anticoagulant control using the national reagent. Journal of Clinical Pathology 23: 281
  • 2 Averdunk R, Börner K. 1974; Standardisierung des Quick-Tests. Referenz-Thromboplastin oder Referenz-Plasmen Blut 28: 445
  • 3 Bangham DR, Biggs R, Brozović M, Denson KW E. 1970. Draft report of a collaborative study of two thromboplastins (including the use of common abnormal plasma). In Koller F, Brinkhous KM, Biggs R, Rodman NF, Hinnom S. (eds.) Vascular Factors and Thrombosis. F. K. Schattauer Verlag; Stuttgart - New York: Thrombosis et Diathesis Haemor- rhagica Suppl., 40 341
  • 4 Bangham DR, Biggs R, Brozović M, Denson KW E. 1973; Calibration of five different thromboplastins, using fresh and freeze-dried plasma. Thrombosis et Diathesis Haemorrhagica 29: 228
  • 5 Bangham DR, Loeliger EA. 1977; Stability of reference thromboplastins. Lancet 2: 1280
  • 6 Beck EA, Muschietti F. 1974; Definition des therapeutischen Bereichs der oralen Antikoagulation. Schweizerische medizinische Wochenschrift 104: 1218
  • 7 Beeser H, Merten R, Drescher H, Fischer J. 1975; A German prothrombin time profiency testing program. Thrombosis et Diathesis Haemorrhagica 33: 152
  • 8 Biggs R. 1965; Report on the standardization of the one-stage prothrombin time for the control of anticoagulant therapy. In Hunter, Wright, Koller, Streuli. (eds.) Genetics and the Interaction of Blood Clotting Factors Thrombosis et Diathesis Haemorrhagica 17 Suppl. p. 303
  • 9 Biggs R, Bangham DR. 1971; Standardization of the one-stage prothrombin time test for the control of anticoagulant therapy: availability and use of thromboplastin reference preparations. British Medical Journal 3: 470
  • 10 Biggs R, Denson KW E. 1967; a Standardization of the one-stage prothrombin time for the control of anticoagulant therapy. British Medical Journal 1: 84
  • 11 Biggs R, Denson KW E. 1967. a Third report on the standardization of the one-stage prothrombin time for the control of anticoagulant therapy. In Brinkhous KM, Wright IS, Soulier JP, Roberts HR, Hinnom S. (eds.) Platelets: their Role in Hemostasis and Thrombosis. F. K. Schattauer Verlag; Stuttgart - New York: Thrombosis et Diathesis Haemor- rhagica, Suppl. 26 445
  • 12 Boyles PW. 1970; Correlation of prothrombin tests with haemorrhage and thromboembolism in patients under long-term anticoagulant therapy. (Paper presented at the Meeting of the American Therapeutic Society, San Francisco.) Clinical Pharmacology and Therapeutics 11: 251
  • 13 British Anticoagulant Panel Recommendation. 1974 Manchester Comparative Reagent and British Comparative Thromboplastin leaflet.
  • 14 Denson KW E. 1969. Fourth report on the standardization of the one-stage prothrombin time for the control of anticoagulant therapy. In Owren PA, Brinkhous KM. (eds.) Proceedings of the International Committee on Thrombosis and Haemostasis. Washington, D. C., December 1967 F. K. Schattauer Verlag; Stuttgart: p 197
  • 15 Duk-Wierda CA, Van Halem-Visser LP, Van Hoeff-Van Halem RA, Van Der. Loeliger EA. 1978; The preparation of control blood for external quality assessment programs in oral anticoagulant control. Thrombosis and Haemostasis 39: 210
  • 16 Duk-Wierda CA, Van Hermans J, Loeliger EA, Roos J. 1977; Interlaboratory oral anticoagulant quality assessment by the Netherlands Federation of Thrombosis Services. Thrombosis and Haemostasis 37: 509
  • 17 Duckert F, Marbet GA. 1977; Die Kontrolle der oralen Antikoagulation - der therapeutische Bereich. Schweizerische Medizinische Wochenschrift 107: 1308
  • 18 Goguel A. 1976; Contrôle de qualité du temps de Quick. Renseignements fournis par les confrontations interlaboratoires “Etalonorme” 1973 à 1975 Feuillets de Biologie 17: 31
  • 19 Goguel A. 1977; Confrontations inter-laboratoires, Etalonorme. Nouvelle Revue Française d’Hématologie 18: 648
  • 20 Goguel A, Houbouyan L, Roussi J. 1977 De l’emploi de plasmas calibrés pour la standardisation du temps de Quick. Une expérience en vraie grandeur pourtant sur 800 laboratoires: Confrontations Interlaboratoires Etalonorme. Document prepared for the Haemostasis and Thrombosis Group of the French Society of Haematology (privately communicated)
  • 21 Hills M, Ingram GI C. 1973; Monitoring successive batches of British Comparative Thromboplastin. British Journal of Haematology 25: 445
  • 22 Kahan J, Noren I. 1975; Assessment of different mathematical models for calculating and expressing the results of coagulation test procedures. Thrombosis et Diathesis Haemorrhagica 34: 522
  • 23 Koepke JA, Gilmer PR, Triplett DA, O’sullivan MB. 1977; The prediction of prothrombin time system performance using secondary standards. American Journal of Clinical Pathology 68: 191 Suppl
  • 24 Korsan-Bengtsen K. 1970; Comparison between various methods used to control dicumarol therapy. Acta Medica Scandinavica 188: 327
  • 25 Lam-Po-Tang PR L C, Poller L. 1975; Oral anticoagulant therapy and its control: an intemation survey. Thrombosis et Diathesis Haemorrhagica 34: 419
  • 26 Lempert H, Poller L. 1960; Evaluation of thrombotest in the control of anticoagulant therapy. Lancet 2: 1115
  • 27 Loeliger EA. 1958; Schlechte Eigenschaft langwirkender Cumarine oder fiir deren Kontrolle ungeeignete Thrombokinase. Schweizerische medizinische Wochenschrift 88: 639
  • 28 Loeliger EA. 1972; Progress in the control of oral anticoagulation. Thrombosis et Diathesis Haemorrhagica 28: 109
  • 29 Loeliger EA. 1973; Laboratory reagents and coagulation assay procedures. Bulletin of the World Health Organization 48: 727
  • 30 Loeuger EA. 1974; Performance characteristics of reference thromboplastins. American Journal of Clinical Pathology 62: 574
  • 31 Loeliger EA, Boekhout-Mussert MJ, Bieger R. 1975; Prolonged continuous heparin treatment. Thrombosis et Diathesis Haemorrhagica 33: 666
  • 32 Loeliger EA, Boekhout-Mussert MJ, Halem-Visser LP Van, Habbema JD E, De Jonge H. 1974; Reliability of laboratory tests for the control of oral anticoagulation. Thrombosis et Diathesis Haemorrhagica 32: 483
  • 33 Loeuger EA, Halem-Visser LP Van. 1975; A simplified thromboplastin calibration procedure for standardization of anticoagulant control. Thrombosis et Diathesis Haemorrhagica 33: 172
  • 34 Loeliger EA, Halem-Visser LP Van. 1979; Biological properties of the thromboplastins and plasmas included in the ICTH/ICSH collaborative study on prothrombin time standardization. Thrombosis and Haemostasis 42: 1115
  • 35 Loeliger EA, Taconis WK, Veltkamp JJ, Hemker HC. 1970. Standardization of results obtained with different thromboplastin preparations. In Owren PA, Brinkhous KM, Wright IS, Roberts HR, Hinnom S, Kiesselbach TH. (eds.) Fibrinogen: Structural, Metabolic and Pathophysiologic Aspects. F. K. Schattauer Verlag; Stuttgart - New York: Thrombosis et Diathesis Haemorrhagica, Suppl 39
  • 36 Miale JB. 1962; Laboratory control of anticoagulant therapy. Journal of the American Medical Association 180: 736
  • 37 Miale JB, Kent JW. 1973; Performance characteristics of reference thromboplastins. American Journal of Clinical Pathology 60: 453
  • 38 Moore CB, Beeler MF. 1961; Thrombotest versus one-stage prothrombin time determination. New England Journal of Medicine 264: 681
  • 39 Murphy EA, Denson KW E. 1970. Statistical analysis of experiments performed in connection with thromboplastin standardisation. Proceedings of the International Committee on Thrombosis and Haemostasis. Princetown, U. S. A. 1968. p 377 F. K. Schattauer Verlag; Stuttgart- New York: 1970
  • 40 Owren PA. 1959; Thrombotest. A new method for controlling anticoagulant therapy Lancet 2: 754
  • 41 Owren PA. 1974; Standardization of thromboplastin reagents and control plasmas. Haematologica 8: 441
  • 42 Owren PA. 1975; Criteria for an acceptable thromboplastin preparation. Thrombosis et Diathesis Haemorrhagica 33: 165
  • 43 Owren PA, AAS K. 1951; The control of dicumarol therapy and the quantitative determination of prothrombin and proconvertin. Scandinavian Journal of Clinical and Laboratory Investigation 3: 201
  • 44 Poller L. 1962; Methods for the laboratory control of short-term anticoagulant therapy. Acta Haematologica 28: 68
  • 45 Poller L. 1964; Thrombotest Reagent and Christmas disease. Lancet 1: 719
  • 46 Poller L. 1967; A national standard for anticoagulant therapy. The Manchester Comparative Reagent Lancet 1: 491
  • 47 Poller L. 1975; The British system for anticoagulant control. Thrombosis et Diathesis Haemorrhagica 33: 157
  • 48 Poller L, Ingram GI C. 1975. Standardization and quality control of anticoagulant control. In Lewis SM, Coster JF. (eds.) Quality Control in Haematology. Academic Press; London-New York: p 160
  • 49 Poller L, Loeliger EA. 1969; Anticoagulants in cardiac infarction. Lancet 1: 464
  • 50 Poller L, Thomson JM. 1969; The interpretation of prothrombin time results: a national survey. British Journal of Haematology 16: 31
  • 51 Poller L, Thomson JM, Alderson MR. 1971; The British system for anticoagulant control and Thrombotest. Journal of Clinical Pathology 24: 143
  • 52 Poller L, Thomson JM, Yee KF. 1977; Stability studies on lyophilized reference thromboplastins for standardization of prothrombin times. Lancet 2: 1019
  • 53 Quick AJ. 1961; Clinical interpretation of the one-stage prothrombin time. Circulation 24: 1422
  • 54 Quick AJ. 1966. Haemorrhagic Diseases and Thrombosis. Lea & Febiger; Philadelphia: p 373
  • 55 Rodman Th, Pastor BH. 1962; Control of anticoagulant therapy with the thrombotest. Journal of the American Medical Association 180: 739
  • 56 Seaman AJ. 1960; Owren’s capillary blood thrombotest for office or bedside control of anticoagulant therapy: an evaluation. Annals of Internal Medicine 53: 914
  • 57 Sevut S. 1962; Venous thrombosis and pulmonary embolism. American Journal of Medicine 33: 703
  • 58 Sevut S, Innes D. 1964; Prothrombin-time and thrombotest in injured patients on prophylactic anticoagulant therapy. Lancet I: 124
  • 59 Tat RJ, Lewis AE. 1962; Levels of equivalence for various measurements of coumarin activity. Journal of the American Medical Association 180: 744
  • 60 Thomson JM, Chart IS. 1970; The system for laboratory control of oral anticoagulant therapy using the British Comparative Thromboplastin. Journal of Medical Laboratory Technology 27: 207
  • 61 Wright IS, Marple CD, Beck DF. 1954; Myocardial infarction and its treatment with anticoagulants. Summary of findings in 1031 cases Lancet 1: 92
  • 62 Zucker S, Cathey MH, Sox PJ, Hall EC. 1970; Standardization of laboratory tests for controlling anticoagulant therapy. American Journal of Clinical Pathology 53: 348