Pharmacodynamic effects on blood coagulation of a new low molecular weight heparin (alfa-LMWH) in healthy volunteers and gynecological surgery patients.
The pharmacodynamic properties of a new LMWH (alfa-LMWH) were investigated in 8 healthy volunteers after single subcutaneous administrations of 7,500, 15,000 and 30,000 anti-XaU doses at weekly intervals. Anti-Xa and anti-IIa heparin activities were monitored together with aPTT, thrombin time, bleeding time and euglobulin lysis time. No relevant changes in bleeding time or major side-effects were ever recorded. A group of 26 patients submitted to gynaecological surgery were then investigated to determine the dosage schedule for prophylaxis of post-operative deep vein thrombosis. Two subgroups received daily subcutaneous doses of 7,500 and 15,000 anti-XaU alfa-LMWH respectively, beginning 2 h before surgery; the third subgroup received 5,000 IU calcium heparin three times daily over the seven postoperative days. The following tests were peri-operatively monitored: anti-Xa heparin activity, aPTT, PT, fibrinogen, Antithrombin III. No differences in intra-operative bleeding or side-effects were recorded. On the basis of the levels of anti-Xa heparin activity and the negligible effects on aPTT, the dose of 7500 anti-XaU was selected at single daily administration for thromboprophylaxis in gynecological surgery.
Department of Angiology, University Hospital S. Orsola, Bologna, Italy.
G
G
Palareti
C
C
Legnani
B
B
Bianchini
G
G
Guazzaloca
M
M
Maccaferri
A
A
Marabini
P
P
De Iaco
S
S
Marcozzi
L
L
Mancini
C
C
Orlandi
D000368:Aged; D001777:Blood Coagulation / Q000187:drug effects*; D015951:Factor Xa; D005260:Female; D005831:Genital Diseases, Female / Q000601:surgery*; D006493:Heparin / Q000494:pharmacology*; D006801:Humans; D008875:Middle Aged; D008970:Molecular Weight; D010314:Partial Thromboplastin Time; D012016:Reference Values; D015842:Serine Proteinase Inhibitors; D013997:Time Factors
D015842:Serine Proteinase Inhibitors; D006493:Heparin; D015951:Factor Xa