Thromb Haemost 2003; 90(03): 483-490
DOI: 10.1160/TH03-01-0004
Platelets and Blood Cells
Schattauer GmbH

Comparison of PFA-100 testing and bleeding time for detecting platelet hypofunction and von Willebrand disease in clinical practice

Emoke Posan
1   Visiting Scientist from University of Debrecen, Faculty of Medicine, 2nd Department of Medicine, Debrecen, Hungary
,
Robert D. McBane II
2   Division of Cardiovascular Medicine, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA
3   Division of Hematology, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA
,
Diane E. Grill
4   Department of Health Services Research, Division of Biostatistics, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA
,
Cheri L. Motsko
3   Division of Hematology, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA
,
William L. Nichols
3   Division of Hematology, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA
› Author Affiliations
Further Information

Publication History

Reiceved 02 January 2003

Accepted after resubmission 25 May 2003

Publication Date:
05 December 2017 (online)

Summary

The PFA-100 instrument (Platelet Function Analyzer, Dade Behring) has been reported to be superior to the bleeding time (BT) as a screening test of primary hemostasis. However evaluation of this device has been principally limited to selected populations.

The study’s aim was to determine testing performance in clinical practice, by comparing the PFA-100 to the BT for the identification of von Willebrand disease (VWD) and intrinsic platelet hypofunction.

From 1998-2000, PFA-100 closure time (CT) for epinephrine-collagen (EPI) and ADP-collagen (ADP) cartridges and modified Ivy BTs were performed on outpatients referred for testing for suspected or known hemorrhagic diathesis (n=346). Evaluation included assays of von Willebrand factor and platelet aggregometry in addition to platelet flow cytometry and electron microscopy when indicated. The normal distribution of PFA-100 CTs was determined using blood samples from 61 normal donors studied on 155 occasions.

Results show that thirty-four patients met the diagnostic criteria for VWD and 31 patients were diagnosed with congenital or acquired intrinsic platelet hypofunction. The sensitivity of the PFA-100 for identification of VWD was significantly better (p<0.01) than the BT with similar specificity. In contrast, the PFA-100 was comparable, but not superior to the BT for detecting platelet hypofunction.

We conclude that the PFA-100 performance compares favor-ably to the BT for the identification of intrinsic platelet hypofunction in clinical practice with superior sensitivity for detecting VWD.Therefore, the PFA-100 could replace the BT for purposes of screening for VWD and intrinsic platelet hypofunction. When clinical suspicion is strong, testing should be supplemented with assays of von Willebrand factor and platelet aggregometry.

 
  • References

  • 1 Mielke CH. Measurement of the bleeding time. Thromb Haemost 1984; 52: 210-11.
  • 2 Rodgers RP, Levin J. A critical reappraisal of bleeding time. Semin Thromb Hemost 1990; 16: 1-20.
  • 3 Lind SE. The bleeding time does not predict surgical bleeding. Blood 1991; 77: 2547-52.
  • 4 De Caterina R, Lanza M, Manca G. et al. Bleeding time and bleeding: an analysis of the relationship of bleeding time test with parameters of surgical bleeding. Blood 1994; 84: 3363-70.
  • 5 Gewirtz AS, Miller ML, Keys TF. The clinical usefulness of the preoperative bleeding time. Arch Pathol Lab Med 1996; 120: 353-6.
  • 6 Ruggeri ZM. Mechanisms initiating platelet thrombus formation. Thromb Haemost 1997; 78: 611-6.
  • 7 Peerschke EIB, Lopez JA. Platelet membranes and receptors. In: Thrombosis and Hemorrhage, second edition. eds Loscalzo J, Schafer AI. Baltimore: Williams and Wilkins; 1998: 229-60.
  • 8 Francis J, Francis D, Larson L. et al. Can the platelet function analyzer (PFA)-100 test substitute for the template bleeding time in routine clinical practice?. Platelets 1999; 10: 132-6.
  • 9 Kerenyi A, Schlammadinger A, Ajzner E. et al. Comparison of PFA-100 closure time and template bleeding time of patients with inherited disorders causing defective platelet function. Thromb Res 1999; 96: 487-92.
  • 10 Nitu-Whalley IC, Lee CA, Griffioen A. et al. Type 1 von Willebrand disease - a clinical retrospective study of the diagnosis, the influence of the ABO blood group and the role of the bleeding history. Br J Haematol 2000; 108: 259-64.
  • 11 Olson JD, Brockway WJ, Fass DN. et al. Evaluation of ristocetin-Willebrand factor assay and ristocetin-induced platelet aggregation. Am J Clin Pathol 1975; 63: 210-8.
  • 12 Ruggeri ZM, Zimmerman TS. Variant von Willebrand’s disease. Characterization of two subtypes by analysis of multimeric composition of FVIII/VWF in plasma and platelets. J Clin Invest 1980; 65: 1318.
  • 13 Ruggeri ZM. Structure and function of von Willebrand factor: relationship to von Willebrand’s disease. Mayo Clin Proc 1991; 66: 847.
  • 14 Sadler JE. A revised classification of von Willebrand disease. Thromb Hemost 1994; 71: 520-5.
  • 15 McBane RD, Elliott MA, White JG. et al. Fechtner syndrome: physiologic analysis of macrothrombocytopenia. Blood Coagul Fibrinolysis 2000; 11: 243-7.
  • 16 DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a non-parametric approach. Biometrics 1988; 44: 837-45.
  • 17 Ortel TL, James AH, Thames EH. et al. Assessment of primary hemostasis by PFA-100 analysis in a tertiary care center. Thromb Hemost 2000; 84: 93-7.
  • 18 Favaloro EJ, Facey D, Henniker A. Use of a novel platelet function analyzer (PFA-100) with high sensitivity to disturbances in von Willebrand factor to screen for von Willebrand’s disease and other disorders. Am J Hematol 1999; 62: 165-74.
  • 19 Escolar G, Cases A, Vinas M. et al. Evaluation of acquired platelet dysfunction in uremic and cirrhotic patients using the platelet function analyzer (PFA-100 ): influence of hematocrit elevation. Haematologica 1999; 84: 614-9.
  • 20 Wahba A, Sander S, Birnbaum DE. Are invitro platelet function tests useful in predicting blood loss following open heart surgery?. Thorac Cardiovasc Surg 1998; 46: 228-31.
  • 21 Favaloro EJ. Utility of the PFA-100 for assessing bleeding disorders and monitoring therapy: a review of analytical variables, benefits and limitations. Haemophilia 2001; 7: 170-9.
  • 22 Kundu SK, Heilmann EJ, Sio R. et al. Description of an in vitro platelet function analyzer – PFA-100. Semin Thromb Hemost 1995; 21: 106-12.
  • 23 Mammen EF, Comp PC, Gosselin R. et al. PFA-100 system: a new method for assessment of platelet dysfunction. Semin Thromb Hemost 1998; 24: 195-202.
  • 24 Fressinaud E, Veyradier A, Truchaud F. et al. Screening for von Willebrand disease with a new analyzer using high shear stress: a study of 60 cases. Blood 1998; 91: 1325-31.
  • 25 Sadler JE, Mannucci PM, Berntorp E. et al. Impact, diagnosis and treatment of von Willebrand disease. Thromb Haemost 2000; 84: 160-74.
  • 26 Fressinaud E, Veyradier A, Sigaud M. et al. Therapeutic monitoring of von Willebrand disease: interest and limits of a platelet function analyser at high shear rates. Br J Haematol 1999; 106: 777-83.
  • 27 Dean JA, Blanchette VS, Carcao MD. et al. von Willebrand disease in a pediatric-based population – comparison of type 1 diagnostic criteria and use of the PFA-100 and a von Willebrand factor/collagen-binding assay. Thromb Haemost 2000; 84: 401-9.
  • 28 Cattaneo M, Federici AB, Lecchi A. et al. Evaluation of the PFA-100 system in diagnosing and therapeutic monitoring of patients with von Willebrand disease. Thromb Hemost 1999; 82: 35-9.
  • 29 Cattaneo M, Lecchi A, Agati B. et al. Evaluation of platelet function with the PFA-100 system in patients with congenital defects of platelet secretion. Thromb Res 1999; 96: 213-7.
  • 30 Peterson P, Hayes TE, Arkin CF. et al. The preoperative bleeding time test lacks clinical benefit. Arch Surg 1998; 133: 134-9.
  • 31 Lind SE.. The Bleeding Time. In: Platelets. Michelson A.D.. ed Elsevier Science, San Diego: Academic Press; 2002: 283-8.