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Correlation between anti-Xa and occurrence of thrombosis and haemorrhage in post-surgical patients treated with either Logiparin (LMWH) or unfractionated heparin. Post-surgery Logiparin Study Group.

Abstract
A total of 1290 patients (Pts) undergoing general surgery were enrolled in a randomized, multicentre double-blind study in order to investigate the efficacy and safety of two different doses of a low molecular weight heparin (LMWH) (Logiparin) for the prevention of deep vein thrombosis. Patients were randomized to either 5,000 IU unfractionated heparin twice daily, 2,500 anti-Xa or 3,500 anti-Xa units of Logiparin once daily. Each treatment was given subcutaneously two hours before surgery and continued for seven to ten days. All coagulation tests were performed blindly in a core laboratory. Blood samples were collected before surgery and then 3 hours after injection on Day 3 and 5 after surgery. Anti-Xa amidolytic activities were significantly higher in the two LMW Heparin groups than in the unfractionated heparin group (mean peak levels +/- s.e.m. on Day 3: 0.097 +/- 0.004; 0.152 +/- 0.004 and 0.034 +/- 0.003 IU respectively). As expected a significant correlation was observed between anti-Xa activity and the dose of LMW Heparin injected. The correlation coefficient was higher when the doses were expressed in anti-Xa units/kg body weight. However, the body weight accounts for only 16% of the interindividual variability of anti-Xa activity. Therefore, there is no clear evidence to suggest that weight-adjusted doses should be recommended when this LMW Heparin is used as prophylactic treatment in general surgery. A weak negative correlation was found between anti-Xa activity and thrombosis as demonstrated by a positive radiolabelled fibrinogen uptake test and confirmed by positive phlebography. No significant correlation was demonstrated between anti-Xa activity and the occurrence of postoperative bleeding.
AuthorsL Bara, A Leizorovicz, H Picolet, M Samama
JournalThrombosis research (Thromb Res) Vol. 65 Issue 4-5 Pg. 641-50 (Mar 01 1992) ISSN: 0049-3848 [Print] United States
PMID1319619 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Factor Xa Inhibitors
  • Heparin, Low-Molecular-Weight
  • Lipoproteins
  • lipoprotein-associated coagulation inhibitor
  • Factor VII
  • Heparin
  • Thromboplastin
Topics
  • Body Weight
  • Double-Blind Method
  • Drug Administration Schedule
  • Factor VII (analysis, antagonists & inhibitors)
  • Factor Xa Inhibitors
  • Female
  • Hemorrhage (prevention & control)
  • Heparin (pharmacology)
  • Heparin, Low-Molecular-Weight (pharmacology)
  • Humans
  • Lipoproteins (analysis)
  • Male
  • Postoperative Period
  • Thromboplastin (analysis, antagonists & inhibitors)
  • Thrombosis (prevention & control)

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