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February 2, 2004British Journal of Haematology

Recombinant factor VIIa reverses the anticoagulant effect of the long‐acting pentasaccharide idraparinux in healthy volunteers

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Why the study?

Does recombinant factor VIIa reverse the anticoagulant effects of idraparinux in healthy male volunteers?

Population

12 healthy male volunteers

Comparison

Recombinant factor VIIa 90 microg/kg intravenous… vs Placebo

Design

RCT, randomized, placebo-controlled

Follow-up

1 week

Authors

NBNick R. BijsterveldElectrophysiologyRVRoel VinkAmerican Legacy FoundationBABenien E. van AkenAmsterdam UMC Location University of Amsterdam

Discussion

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Implication

rFVIIa may aid idraparinux reversal in bleeding; confirms surrogate efficacy in this RCT of healthy volunteers.

Structured PICO

Does recombinant factor VIIa reverse the anticoagulant effects of idraparinux in healthy male volunteers?

P
Population
12 healthy male volunteers
I
Intervention
Recombinant factor VIIa (rFVIIa) 90 microg/kg intravenous (i.v.) administered either 3 hours or 1 week after idraparinux 7.5 mg subcutaneous (s.c.)
C
Comparator
Placebo
O
Outcome
Reversal of anticoagulant effect measured by thrombin generation time (TGT), activated partial thromboplastin time (aPTT), prothrombin time (PT), prothrombin fragment 1+2 (F1+2) levels, and endogenous thrombin potential (ETP)surrogate

Recombinant factor VIIa effectively reverses the surrogate coagulation parameters altered by idraparinux, suggesting potential utility for managing serious bleeding complications.

Cite This Study

Bijsterveld et al. (2004) studied this question.

synapsesocial.com/papers/6a904ff1e8d327d5003424bfhttps://doi.org/10.1111/j.1365-2141.2003.04811.x
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The effect of recombinant factor VIIa (NovoSeven???) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.01998 · 172 citations
  2. 2A Synthetic Pentasaccharide for the Prevention of Deep-Vein Thrombosis after Total Hip Replacement2001 · 382 citations
  3. 3Identification of Active Tissue Factor in Human Coronary Atheroma1996 · 255 citations
  4. 4Fondaparinux: a synthetic heparin pentasaccharide as a new antithrombotic agent2002 · 121 citations
  5. 5Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Elective Major Knee Surgery2001 · 668 citations