Heparin quality control in the Brazilian market: implications in the cardiovascular surgery

Rev Bras Cir Cardiovasc. 2008 Apr-Jun;23(2):169-74. doi: 10.1590/s0102-76382008000200004.
[Article in English, Portuguese]

Abstract

Introduction: The change in the heparin solution trade mark in Brazil that had been commonly used in cardiac surgery has shown increased number in the coagulopathy, re-exploration and other side effects in our Institution and others.

Methods: All four different heparin solutions available in the Brazilian market were studied in the Connective Tissue Lab, HUCFF, UFRJ and compared to the Liquemine (out of the market) and the international control solution. All samples were evaluated by magnetic nuclear resonance as well as their anticoagulant effectiveness.

Results: There were significant differences among them regarding the anticoagulant activity. It was also observed contamination with other dermatan sulfate, samples chemically degraded and with significant change in the molecular weight.

Conclusion: Among the studied samples, none of them can offer security in cardiac surgeries on pump. None of them has demonstrated similar quality to Liquemine, which is not available in the Brazilian market.

Publication types

  • Comparative Study

MeSH terms

  • Anticoagulants / blood
  • Anticoagulants / chemistry
  • Anticoagulants / standards*
  • Brazil
  • Cardiovascular Surgical Procedures*
  • Chromatography, Gel
  • Dermatan Sulfate / blood
  • Drug Contamination
  • Drug Industry / standards*
  • Heparin / blood
  • Heparin / chemistry
  • Heparin / standards*
  • Hexuronic Acids / blood
  • Humans
  • Magnetic Resonance Spectroscopy
  • Molecular Weight
  • Partial Thromboplastin Time
  • Quality Control
  • Reference Standards

Substances

  • Anticoagulants
  • Hexuronic Acids
  • Dermatan Sulfate
  • Heparin