Nonclinical evaluation of novel cationically modified polysaccharide antidotes for unfractionated heparin

PLoS One. 2015 Mar 17;10(3):e0119486. doi: 10.1371/journal.pone.0119486. eCollection 2015.

Abstract

Protamine, the only registered antidote of unfractionated heparin (UFH), may produce a number of adverse effects, such as anaphylactic shock or serious hypotension. We aimed to develop an alternative UFH antidote as efficient as protamine, but safer and easier to produce. As a starting material, we have chosen generally non-toxic, biocompatible, widely available, inexpensive, and easy to functionalize polysaccharides. Our approach was to synthesize, purify and characterize cationic derivatives of dextran, hydroxypropylcellulose, pullulan and γ-cyclodextrin, then to screen them for potential heparin-reversal activity using an in vitro assay and finally examine efficacy and safety of the most active polymers in Wistar rat and BALB/c mouse models of experimentally induced arterial and venous thrombosis. Efficacy studies included the measurement of thrombus formation, activated partial thromboplastin time, bleeding time, and anti-factor Xa activity; safety studies included the measurement of hemodynamic, hematologic and immunologic parameters. Linear, high molecular weight dextran substituted with glycidyltrimethylammonium chloride groups at a ratio of 0.65 per glucose unit (Dex40-GTMAC3) is the most potent and the safest UFH inhibitor showing activity comparable to that of protamine while possessing lower immunogenicity. Cationic polysaccharides of various structures neutralize UFH. Dex40-GTMAC3 is a promising and potentially better UFH antidote than protamine.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antidotes / pharmacology*
  • Blood Pressure / drug effects
  • Cations / chemistry*
  • Female
  • Heparin / chemistry*
  • Heparin / metabolism
  • Heparin Antagonists / pharmacology*
  • Immunization
  • Male
  • Mice
  • Mice, Inbred BALB C
  • Partial Thromboplastin Time
  • Polymers / chemistry
  • Polymers / pharmacology*
  • Polysaccharides / chemistry
  • Protamines / metabolism
  • Rats
  • Rats, Wistar
  • Thrombosis / drug therapy*
  • Thrombosis / immunology*
  • Thrombosis / metabolism

Substances

  • Antidotes
  • Cations
  • Heparin Antagonists
  • Polymers
  • Polysaccharides
  • Protamines
  • Heparin

Grants and funding

The study was supported by National Science Centre Grant No. DEC-2011/03/B/NZ7/00755. BK was supported by funds from Leading National Research Center in Bialystok (31/KNOW/2013). KK was supported by National Science Centre Grant No. UMO-2013/09/D/ST5/03864. KK, KS, and MN acknowledge the financial support of the Foundation for Polish Science Team Programme co-financed by the EU European Regional Development Fund, PolyMed, TEAM/2008-2/6. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.