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.
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Authors | L Bara, A Leizorovicz, H Picolet, M Samama |
Journal | Thrombosis research
(Thromb Res)
Vol. 65
Issue 4-5
Pg. 641-50
(Mar 01 1992)
ISSN: 0049-3848 [Print] United States |
PMID | 1319619
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Factor Xa Inhibitors
- Heparin, Low-Molecular-Weight
- Lipoproteins
- lipoprotein-associated coagulation inhibitor
- Factor VII
- Heparin
- Thromboplastin
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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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