Standards in Fibrinolysis – Current Status and Future Challenges

Patrick J Gaffney

doi:10.1055/s-0038-1649952

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1995; 74(06): 1389-1397
DOI: 10.1055/s-0038-1649952

Review Article

Schattauer GmbH Stuttgart

Standards in Fibrinolysis – Current Status and Future Challenges

Patrick J Gaffney

The Division of Haematology, National Institute for Biological Standards and Control, South MImms, Potters Bar, Hertfordshire, UK

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Abstract

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References

References
1 Barrowcliffe TW. The use of standards in blood coagulation. In: Blood Coagulation and Haemostasis. Thompson H. ed. Churchill Livingstone; Edinburgh, UK: 1985: 410-432
2 Barrowcliffe TW, Curtis AD. Principles of bioassay. In: Haemostasis and Thrombosis. Bloom AL, Thomas DP. eds Churchill Livingstone; Edinburgh, UK: 1987: 996-1004
3 Verstraete M. A far-reaching programme; rapid, safe and predictable thrombolysis in man. In: Fibrinolysis. Kline DL, Reddy NN. eds. CRC Press, Boca Raton; Florida, USA: 1980: 129-149
4 Camiolo SM, Thorsen S, Astrup T. Fibrinogenolysis and fibrinolysis with tissue plasminogen activator, urokinase, streptokinase-activated human globulin and plasmins. Proc Soc Exp Biol Med 1971; 38: 277-280
5 Pennica D, Holmes WE, Kohr WJ, Harkins RN, Vehar GA, Ward CA, Bennett WF, Yelverton E, Seeburg PH, Heyneker HL, Goeddel DV, Collen D. Cloning and expression of human tissue-type plasminogen activator cDNA in E. coli.. Nature 1983; 301: 214-221
6 Krause J. Catabolism of tissue-type plasminogen activator (t-PA), its variants, mutants and hybrids. A review Fibrinolysis 1988; 2: 133-142
7 Hoylaerts M, Rijken DC, Lijnen HR, Collen D. Kinetics of the activation of plasminogen by human tissue plasminogen activator. Role of fibrin J Biol Chem 1982; 257: 2912-2919
8 Verstraete M, Bleifeld W, Brower RW, Charbonnier B, Collen D, de Bono DP, Dunning AJ, Lennane RJ, Lubsen J, Mathey DG, Michel PL, Raynaud Ph, Schofer J, Vahanian A, Vanhaecke J, Van de Kley GA, Van de Werf F, Von Essen R. Double-blind randomised trial of intravenous tissue-type plasminogen activator versus placebo in acute myocardial infarction. Lancet 1985; 2: 965-969
9 Wilcox RG, von der Lippe G, Olsson CG, Jensen G, Skene AM, Hampton JR. Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction. Anglo-Scandinavian Study of Early Thrombolysis (ASSET) Lancet 1988; 2: 525-539
10 Gaffney PJ, Curtis AD. A collaborative study of a proposed international standard for tissue plasminogen activator (t-PA). Thromb Haemost 1985; 53: 134-136
11 Gaffney PJ, Curtis AD. A collaborative study to establish the 2nd International Standard for tissue plasminogen activator (t-PA). Thromb Haemost 1987; 58: 1085-1087
12 Parekh RB, Dwek RA, Thomas JR, Opdenakker G, Rademacher TW, Wittwer AJ, Howard SC, Nelson R, Siegel NR, Jennings MG, Harakas NK, Feder J. Cell-type specific and site specific N-glycosylation of Type I and Type II human tissue plasminogen activator. Biochemistry 1989; 28: 7644-7662
13 Chan AL, Morris HR, Panico M, Etienne AT, Rogers ME, Gaffney PJ, Creighton-Kempsford L, Dell A. A novel sialylated N-acetylgalactosamine containing oligosaccharide is the major complex-type structure present in Bowes melanoma tissue plasminogen activator. Glycobiology 1991; 1: 173-185
14 Burck PJ, Berg DH, Warrick MW, Berg DT, Walls JD, Jaskunas SR, Crisel RM, Weigel B, Vlajos CJ, McClure DB, Grinnell BW. Characterisation of a modified human tissue plasminogen activator comprising a kringle-2 and a protease domain. J Biol Chem 1990; 265: 5170-5177
15 Kohnert U, Rudolph R, Verheijen JH, Weening-Verhoeff EJ, Stem A, Opitz U, Martin U, Lill H, Prinz H, Lechner M, Kresse G-B, Buckel P, Fischer S. Deletion of the three N-terminal domains still maintains the biochemical properties of the protease and the kringle-2 in the refolded t-PA deletion mutant BM 06.022. Prot Engineering 1992; 5: 93-100
16 Martin U, Fischer S, Kohnert U, Rudolph R, Sponer G, Stem A, Strein K. Pharmacokinetic properties of an Escherichia coli-produced recombinant plasminogen activator (BM 06.022) in rabbits. Thromb Res 1991; 62: 137-146
17 Gaffney PJ, Creighton-Kempsford LJ, Pring JB. Assessment of the international standard for tissue plasminogen activator as a standard for domainally-deleted mutants. Thromb Haemost 1993; 69: 1264 (abstract)
18 Kratzschmar J, Haendler B, Langer G, Boidol W, Bringmann P, Alagon A, Donner P, Schleuning WD. The plasminogen activator family from the salivary gland of the vampire bat Desmodus rotundus: cloning and expression. Gene 1991; 105: 229-237
19 Castellino FJ. A unique enzyme-protein substrate modifier reaction: plasmin/streptokinase interaction. Trends Biochem Sci 1979; 4: 1-5
20 Heath AB, Gaffney PJ. A collaborative study to establish the second international standard for streptokinase. Thromb Haemost 1990; 64: 267-269
21 Collen D, Silence K, Demarsin E, De Mol M, Lijnen HR. Isolation and characterisation of natural and recombinant staphylokinase. Fibrinolysis 1992; 6: 203-213
22 Collcn D, De Cock F, Vanlinthoul I, Dcclcrck PJ, Lijncn HR, Stassen JM. Comparative thrombolytic and immunogenic properties of staphylokinase and streptokinase. Fibrinolysis 1992; 6: 232-242
23 Husain S, Clurewieh V, Lipinski B. Purification and partial characterisation of a single chain high molecular weight form of urokinase from human urine. Arch Bioehem Biophys 1983; 220: 31-38
24 Urano T, de Serrano SV, Gaffney PJ, Castellino FJ. Activation of human (glu*) plasminogen by human single chain urokinase. Arch Bioehem Biophys 1988; 264: 222-230
25 Priini Trial Study Group. Randomised double-blind trial of recombinant prourokinase against streptokinase in acute myocardial infarction. Lancet 1989; 1: 863-867
26 Lijnen HR, Nelles L, Holmes WE, Collcn D. Biochemical and thrombolytic properties of a low molecular weight form (comprising leu¹⁴⁴ through leu⁴¹¹) of recombinant single chain urokinase-type plasminogen activator. J Biol Chcm 1988; 263: 5594-5598
27 Philo RD, Gaffney PJ. Assay methodology for urokinase. Its use in assessing the composition of mixtures of high- and low-molecular weight urokinases. Thromb Res 1981; 21: 81-88
28 World Health Organisation. Twenty-first Meeting. Hxpert Committee on Biological Standardisation WHO Tech Rep Ser No 413 1968
29 Philo RD, Gaffney PJ. Relative potencies of different molecular weight forms of urokinase. In: Prog Fibrinolysis Thrombolysis. Davidson JF, Nilsson I-M, Samama MM, Dcsnoycrs PC. eds. Churchill Livingstone; Edingburgh: 1981. Vol 5 220-2
30 Gaffney PJ, Heath AB. A collaborative study to establish a standard for high molecular weight urinary-type plasminogen activator (HMW/u-PA). Thromb Haemost 1990; 64: 398-401
31 Hanbueken FW, Schneider J, Gunzler WA. Selective fibrinolytic activity of recombinant non-glycosylated human prourokinase (single chain urokinase-type plasminogen activator) from bacteria. Drug Res 1987; 37: 993-997
32 Nolli ML, Sarubbi E, Robbiati F, Soffientini A, Blasi F, Parenti F, Cassani G. Production and characterisation of human recombinant single chain urokinase-type plasminogen activator from mouse cells. Fibrinolysis 1989; 3: 101-6
33 Report of the Fibrinolysis Subcommittee of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis (Chairman HR Lijnen. 1993
34 Clough AM, Gaffney PJ, Longstaff C. Comparison of high and low molecular weight urokinase activities in a variety of assay systems. Fibrinolysis 1992; 6 suppl (Suppl. 02) 210 (abstract)
35 Gallimore MJ, Nulkar MV, Shaw JT B. A comparative study of the inhibitors of fibrinolysis in human, dog and rabbit blood. Thromb Diath Haemorrh 1965; 14: 145-158
36 Fibrinolysis BrakmanP. A standardised fibrin plate method and a fibrinolytic assay of plasminogen. Scheltema and Holkema; Amsterdam: 1967
37 Mahmoud M, Gaffney PJ. Bioimmunoassay (BIA) of tissue plasminogen activator (t-PA) and its specific inhibitor (t-PA/INH). Thromb Haemost 1985; 53: 356-359
38 Gaffney PJ, Wong M-Y. Collaborative study of a proposed international reference reagent (IRR) for human plasma fibrinogen. Thromb Haemost 1992; 68: 428-432
39 Gaffney PJ. Interlaboratory evaluation of the International Standard for plasma fibrinogen in the automated Clauss procedure. (Mss in preparation)
40 Meade TW. Hypercoagulability and ischaemic heart disease. Blood Rev 1987; 1: 2-8
41 Philo RD, Gaffney PJ. Plasmin potency estimates. Influence of the substrate used in the assay Thromb Haemost 1981; 45: 107-109
42 Hamsten A, Wiman B, de Faire U, Blombilck M. Increased plasma levels of a rapid inhibitor of tissue plasminogen activator in young survivors of myocardial infarction. N ling J Med 1985; 313: 1557-1563
43 Declerck PJ, Moreau I I, Jespersen J, Gram J, Kluft C. Multicenter evaluation of commercially available methods lor the immunological determination of plasminogen activator inhibitor-1 (PAI-I). Thromb Haemost 1993; 70: 858-863
44 Gram J, Declerck PJ, Sidclmann J, Jespersen J, Kluft C. Multicenter evaluation of commercial kit methods: plasminogen activator inhibitor activity. Thromb Haemost 1993; 70: 852-857
45 Wagner OF, Binder B. Purification of an active plasminogen activator inhibitor immunologically related to the endothelial type plasminogen activator inhibitor from the conditioned media of a human melanoma cell line. J Biol Chem 1986; 261: 14474-14481
46 Alessi MC, Declerck PJ, De Mol M, Nelles L, Collcn D. Purification and characterisation of natural and recombinant human plasminogen activator inhibitor-1 (PAI-I). Eur J Bioch 1988; 175: 531-40
47 Donati M-B. Assays for fibrinogen/fibrin degradation products in biological fluids: some methodological aspects. Thromb Diath Haemorrh 1975; 34: 652-660
48 Rylatt DB, Blake AS, Cottis LE, Massingham DA, Fletcher WA, Masci PP, Whitaker AN, Elms M, Bunce I, Webber AJ, Wyatt D, Bundeson PG. An immunoassay for human D dimer using monoclonal antibodies. Thromb Res 1983; 31: 767-778
49 Gaffney PJ. FDP. Lancet 1972; 2: 1422
50 Gaffney PJ. Structure of fibrinogen and degradation products of fibrinogen and fibrin. Brit Med Bull 1977; 33: 245-52
51 Gaffney PJ, Edgell TA, Creighton-Kempsford LJ, Wheeler S, Tarelli E. Fibrin degradation product (FnDP) assays. Analysis of standardisation issues and target antigens in plasma Br J Haem 1995; 90: 187-194
52 Creighton LJ, Gaffney PJ. Appraisal of an ELISA procedure for the measurement of FDP in plasma. Fibrinolysis 1988; 2 suppl (Suppl. 01) 39 (abstract)
53 Graeff H, Hafter R. Detection and relevance of crosslinked fibrin derivatives in blood. Sem Thromb Haemost 1982; 8: 57-68
54 Gaffney PJ, Gascoine PS, Creighton LJ, Tymkewycz PM. Monoclonal antibodies for the detection of thrombosis. Adv Exp Med Biol 1990; 281: 419-427
55 Creighton-Kempsford LJ, Pring JB, Gaffney PJ. A comparison of the plasminogen activator activity units of urinary-type plasminogen activator (u-PA) and tissue plasminogen activator (t-PA). Blood Coag Fibrinolysis 1992; 3: 481-483
56 Smith RA C, Dupe RJ, English PD, Green J. Fibrinolysis with acyl- enzymes: a new approach to thrombolytic therapy. Nature 1981; 290: 505-508
57 Longstaff C, Wong M-Y, Gaffney PJ. An international collaborative study to investigate the standardisation of hirudin potency. Thromb Haemost 1993; 69: 430-435
58 Gaffney PJ, Heath AB, Fenton II JW. A collaborative study to establish an international standard for a-thrombin. Thromb Haemost 1992; 67: 424-427
59 Gaffney PJ, Creighton LC, Mahmoud-Alexandroni M. Assays associated with fibrinolysis. In: Fibrinolysis. Current Prospects Gaffney PJ, Castellino FJ, Plow E, Takada A. eds. John Libby and Son; London: 1988: 129-140