Clinical Experience with the Thrombostat 4000

Abstract

Bleeding times are presently widely used to screen patients with primary hemostasis defects although their accuracy and reliability has been questioned by many investigators. Platelet aggregation studies are not suited for routine use. We investigated the performance characteristics of the Thrombostat 4000, a device that assesses primary hemostasis. Tests can be performed by adding ADP, epinephrine, CaCl₂ or NaCl to the collagen onto which platelets adhere. It was found, using normal volunteers and patients, that ADP and epinephrine had acceptable reference ranges with coefficients of variance between 9–12% for within run and between runs. However, major differences were seen when different filter badges were used–a reflection of differences in collagen. Regular citrated blood, routinely drawn for coagulation studies, can be used; test performance can be delayed for up to five hours when the blood is kept at room temperature. The effects of aspirin on volunteers could be detected when epinephrine was used, but not with ADP. ADP addition allowed the detection of more patients with primary hemostasis defects than bleeding times, and epinephrine was as useful as ADP in detecting these abnormalities. The data suggest that the broadest spectrum of platelet defects (ASA use and platelet dysfunction) can be detected with epinephrine. Inconsistencies in collagen used for coating of the filters is a major drawback for the routine use of this device in screening primary hemostasis defects.

Keywords

platelets - primary hemostasis - platelet function - Thrombostat - bleeding time

• References

• 1 Duke WW. The relation of blood platelets to hemorrhagic disease: description of a method for determining the bleeding time and coagulation time and report of three cases of hemorrhagic disease relieved by transfusion. JAMA 55: 1185-1192 1910;
• 2 Rodgers RPC, Levin J. A critical reappraisal of the bleeding time. Semin Thromb Hemost 16: 1-20 1990;
• 3 Blakely J, Prchal JT, Glynn MFX. An in vitro measurement of bleeding time. J Lab Clin Med 89: 1306-1313 1977;
• 4 Didisheim P, Claypool DA, Stropp JQ, Baker RW. The teflon tubing bleeding time in man. Thromb Haemost 46 (131 (abst)) 1981;
• 5 Uchiyama S, Stropp JA, Claypool DA, Didisheim P, Dewanjee MK. Filter bleeding time: A new in vitro test of hemostasis. 1. Evaluation in normal and thrombocytopenic subjects. Thromb Res 31: 99-116 1983;
• 6 Gorby P, Ahmed A. Haemostatometer: A new in vitro bleeding technique for assessing hemostasis activity of blood. Thromb Res 34: 341-357 1984;
• 7 Kratzer MAA, Born GVR. Simulation of primary hemostasis in vitro. Haemostasis 15: 357-362 1985;
• 8 DeCaterina R, Lanza M, Manca G, Strata GB, Maffei S, Salvatore L. Bleeding time and bleeding: An analysis of the relationship of the bleeding time test with parameters of surgical bleeding. Blood 84: 3363-3370 1994;
• 9 MacDonald JD, Remington BJ, Rodgers GM. The skin bleeding time test as a predictor of brain bleeding time in a rat model. Thromb Res 76: 535-540 1994;
• 10 Kratzer MAA, Bellucci S, Caen JP. Detection of abnormal platelet function with an in vitro model of primary hemostasis. Haemostasis 15: 363-370 1985;
• 11 Kratzer M, Knedel M. Evaluation and standardization of the “in vivo” bleeding time technique. Thromb Haemost 58 (389 (abst)) 1987;
• 12 Tsujinaka T, Itoh T, Uemum Y, Saken M, Kambayashi J, Morie T. Clinical application of a new in vitro bleeding time device on surgical patients. Jap J Surg 18: 430-437 1988;
• 13 Maurine N. The in vitro bleeding time while using a stable prostacyclin analogue during hemodialysis. Int J Artificial Organs 11: 243-248 1988;
• 14 Kretschmer V, Schikor B, Söhngen D, Dietrich G. In vitro bleeding test-a simple method for the detection of aspirin effects on platelet function. Thromb Res 56: 593-602 1989;
• 15 Kretschmer V, Schikor B, Söhngen D, Dietrich G. In vitro bleeding test-a sensitive method for the detection of platelet function impairment and a potential test for the control of low-dose aspirin efficacy. Blut 59 (188 (abst)) 1989;
• 16 Dietrich G, Kretschmer V, Orth D, Haupt W. Primary haemostasis in hemodilution I-Hematocrit. Infusionstherapie 17: 212-213 1990;
• 17 Dietrich G, Orth D, Haupt W, Kretschmer V. Primary hemostasis in hemodilution 2-infusion solutions. Infusionstherapie 17: 214-216 1990;
• 18 Kretschmer V, Huss B, Dietrich G, Heymanns J, Pflüger K-H. Determination of bleeding risk in thrombocytopenic patients receiving platelet substitution. Transfus Sci 14: 27-34 1993;
• 19 Alshameeri R, Mammen EF. Evaluation of an in vitro bleeding time device, Thrombostat 4000. Thromb Haemost 69 (2161 (abst)) 1993;
• 20 Hägman CF, Eriksson L, Kristensen J. Leukocyte-depleted platelets prepared from pooled buffy coat. Post-transfusion increment and “in vitro bleeding time” using the Thrombostat 4000/2. Transf Sci 14: 35-39 1993;
• 21 Dietrich G, Weber D, Kretschmer V. The in vitro bleeding test. Standardization of the methodical procedure. Lab Med 17: 317-323 1993;
• 22 Kristensen J, Eriksson L, Olsson K, Killander A, Hägman C. functional capacity of transfused platelets estimated by the Thrombostat 4000/2. Eur J Haematol 51: 152-155 1993;
• 23 Böck M, Glaser A, Pfosser A, Schleuning M, Heim MU, Mempel W. Storage of single-donor platelet concentrates: metabolic and functional changes. Transfusion 33: 311-315 1993;
• 24 Tabuchi N, de Haan J, van Deveren W. Rapid recovery of platelet function after cardiopulmonary bypass. Blood 82: 2930-2931 1993;
• 25 Tabuchi N, de Haan J, Boonstra PW, Gallandat Huet RCG, van Oeveren W. Aprotinin effect on platelet function and clotting during cardiopulmonary bypass. Eur J Cardiothorac Surg 8: 87-90 1994;
• 26 Saleh AA, Ginsburg KA, Duchon TA, Dorey LG, Hirata J, Alshameeri RS, Dombrowski MP, Mammen EF. Hormonal contraception and platelet physiology. Thromb Res in press
• 27 Alshameeri RS, Mammen EF. Performance characteristics and clinical evaluation of an in vitro bleeding time device—Thrombostat 4000. Submitted 1995;
• 28 Richard-Davis G, Montgomery-Rice V, Alshameeri RS, Ginsburg KA, Moghissi KS, Mammen EF. Primary hemostasis in controlled ovarian hyperstimulation. (submitted) 1995;