title: [Treatment of deep venous thrombosis. Comparative study of a low molecular weight heparin fragment (Fragmin) by the subcutaneous route and standard heparin by the continuous intravenous route. A multicenter study].
abstract: This open, randomised multicenter trial compares the efficacy and safety of Fragmin administered subcutaneously twice daily with standard heparin administered by continuous infusion in the treatment of deep vein thrombosis (DVT). The initial dose of Fragmin is 100 U anti-Xa/kg/12 h and the further doses are adjusted according to the anti-Xa activity between 0.5 and 0.8 U/ml, 3 hours after the morning injection. The initial dose of standard heparin is 240 UI/kg/12 h. The dose adjustments are based on the daily results of APTT (1.5 - 3 times the control). Treatments efficacy are appreciated when comparing the venography performed before and after 10 days of treatment. The safety is evaluated on clinical parameters and iterative biological tests. Sixty-six patients have been included in this study. Efficacy of the two treatments is equivalent with a phlebographic improvement in respectively 79.3 p. 100 (Heparin Group) and 71.0 p. 100 (Fragmin Group) of the cases and an aggravation in 3.4 p. 100 and 6.4 p. 100 (NS) respectively. The frequency of dosage adjustments is lower and the stability of biological tests is better in the Fragmin group. In conclusion, the administration of Fragmin twice daily by subcutaneous route seems to be equivalent at least to standard heparin continuous infusion in the treatment of recent DVT. The better convenience and safety of Fragmin have to be verified on a larger panel of patients.
authors.affiliation: CHU Broussais, Paris.
authors.forename: M
authors.initials: M
authors.lastname: Aiach
authors.forename: J N
authors.initials: JN
authors.lastname: Fiessinger
authors.forename: J F
authors.initials: JF
authors.lastname: Vitoux
authors.forename: A
authors.initials: A
authors.lastname: Derlon
authors.forename: G
authors.initials: G
authors.lastname: Grollier
authors.forename: A
authors.initials: A
authors.lastname: Le Querrec
authors.forename: M
authors.initials: M
authors.lastname: Gouault-Heilmann
authors.forename: Y
authors.initials: Y
authors.lastname: Huet
authors.forename: A
authors.initials: A
authors.lastname: Franco
authors.forename: B
authors.initials: B
authors.lastname: Polack
authors.forename: P
authors.initials: P
authors.lastname: Pouzol
authors.forename: A
authors.initials: A
authors.lastname: Dubois
authors.forename: J F
authors.initials: JF
authors.lastname: Schved
authors.forename: B
authors.initials: B
authors.lastname: Boneu
authors.forename: J
authors.initials: J
authors.lastname: Guittard
authors.forename: P
authors.initials: P
authors.lastname: Sie
authors.forename: J J
authors.initials: JJ
authors.lastname: Heilmann
authors.forename: A
authors.initials: A
authors.lastname: Kher
authors.forename: I
authors.initials: I
authors.lastname: Haye
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000627:therapeutic use; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011897:Random Allocation; D013924:Thrombophlebitis / Q000188:drug therapy*
chemical_list: D006495:Heparin, Low-Molecular-Weight; D006493:Heparin
vernacular_title: Traitement des thromboses veineuses profondes constituées. Etude comparative d'un fragment d'héparine de bas poids moléculaire (Fragmine) administrée par voie sous-cutanée et de l'héparine standard administrée par voie intraveineuse continue. Etude multicentrique.