Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double-blind, placebo-controlled, randomized study in cancer patients.
OBJECTIVE
The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE.


METHODS
In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications.


RESULTS
Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period.


CONCLUSIONS
In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.
Verso
Melina
M
Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico dal Pozzo, 06123 Perugia, Italy.
Agnelli
Giancarlo
G
Bertoglio
Sergio
S
Di Somma
Franco C
FC
Paoletti
Francesco
F
Ageno
Walter
W
Bazzan
Mario
M
Parise
Pasquale
P
Quintavalla
Roberto
R
Naglieri
Emanuele
E
Santoro
Armando
A
Imberti
Davide
D
Sorarù
Mariella
M
Mosca
Stefano
S
D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage*; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002408:Catheters, Indwelling / Q000009:adverse effects; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D010690:Phlebography; D010919:Placebos; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000517:prevention & control*
D000925:Anticoagulants; D017984:Enoxaparin; D010919:Placebos