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Effect of activated prothrombin complex concentrate or recombinant factor VIIa on the bleeding time and thrombus

M Elg1, S Carlsson, D Gustafsson

  • 1Department of Cardiovascular Pharmacology, AstraZeneca R&D, S-431 83 Mölndal, Sweden. margareta.elg@astrazeneca.com

Thrombosis Research
|March 3, 2001
PubMed
Abstract

Insights

Activated prothrombin complex concentrate (APCC, Feiba) effectively reversed bleeding caused by melagatran in rats. Recombinant factor VIIa (r-F VIIa, NovoSeven) showed less reversal effect, with no increased thrombosis risk for Feiba.

Area of Science:

  • Pharmacology
  • Hematology
  • Thrombosis Research

Background:

  • Melagatran, an oral direct thrombin inhibitor, demonstrates antithrombotic properties in animal models.
  • Reversal of anticoagulation may be critical in emergency situations for all anticoagulant therapies.
  • Investigating effective reversal agents for melagatran-induced anticoagulation is essential.

Purpose of the Study:

  • To evaluate the hemostatic and prothrombotic effects of activated prothrombin complex concentrate (APCC, Feiba) and recombinant factor VIIa (r-F VIIa, NovoSeven) in reversing melagatran-induced anticoagulation in rats.

Main Methods:

  • Rats were administered high doses of melagatran.
  • Increasing doses of APCC (Feiba) or r-F VIIa (NovoSeven) were superimposed on melagatran or saline.
  • Hemostatic effects were assessed using bleeding time models, and prothrombotic potential was evaluated in an arterial thrombosis model.

Main Results:

  • APCC (Feiba) significantly reduced bleeding time and blood loss in melagatran-treated rats at doses ≥25 U/kg.
  • APCC (Feiba) at doses ≥50 U/kg significantly reduced bleeding time when added to melagatran.
  • No potentiation of thrombus formation was observed with APCC (Feiba) addition.
  • r-F VIIa (NovoSeven) showed a trend towards reduced blood loss and bleeding time at high doses, but less pronounced than Feiba.
  • Feiba more effectively shortened prothrombin time (PT) and ecarin clotting time (ECT) compared to NovoSeven.
  • NovoSeven more effectively shortened whole blood clotting time (WBCT) than Feiba.
  • NovoSeven shortened activated partial thromboplastin time (APTT), while Feiba prolonged it.
  • Thrombin-antithrombin (TAT) complex formation increased more effectively with Feiba than NovoSeven.

Conclusions:

  • Feiba (APCC) effectively reversed melagatran-induced prolonged bleeding time and blood loss in rats without potentiating thrombus formation.
  • NovoSeven (r-F VIIa) demonstrated less pronounced effects on blood loss and bleeding times compared to Feiba at high doses.

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