Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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Clin. Appl. Thromb. Hemost. · Jan 2003
Randomized Controlled Trial Comparative Study Clinical TrialEffects of PEG-hirudin in clotting parameters and platelet function and its interaction with aspirin in healthy volunteers.
The purpose of this study was to investigate the pharmacodynamics of PEG-Hirudin and its potential interactions with acetylsalicylic acid (ASA 325 mg once daily from days 1-3). In a randomized, 2-way cross-over trial, 6 healthy volunteers received PEG-Hirudin (i.v. bolus of 0.2 mg/kg + 0.02 mg/kg/h for 24 hours) and placebo (i.v. bolus + 24-hour infusion). In a further randomized, 3-way cross-over trial another 9 healthy volunteers received ASA (325 mg) or oral placebo from days 1 to 3 and PEG-Hirudin (0.2 mg/kg + 0.02 mg/kg/h for 24 h) or i.v. placebo on day 3. ⋯ PEG-Hirudin (0.2 mg/kg + 0.02 mg/kg/h for 24 hours) administered alone or together with 325 mg ASA proved to be safe in healthy volunteers. Combined use of PEG-Hirudin and ASA significantly increased the mean bleeding time compared to ASA or PEG-Hirudin monodrug administration. None of the clotting parameters or platelet function tests correlated with the prolongation of the bleeding time.
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Clin. Appl. Thromb. Hemost. · Oct 2002
Randomized Controlled Trial Clinical TrialLow-molecular-weight heparin in arterial reconstructive surgery: a double-blind, randomized dose-finding trial.
Periprocedural and postprocedural anticoagulation during arterial reconstructive surgery (ARS) with intravenous heparin is standard of care. The general use and correct dosage of low-molecular-weight heparin, however, are still under debate. A prospective, randomized, double-blind trial was performed with a parallel group comparison of four dose regimen of a low-molecular-weight heparin, reviparin sodium, in patients undergoing major ARS. ⋯ Thus, the optimal dose of reviparin sodium to be administered in patients undergoing major ARS is half the therapeutic dose: 5950 to 6300 anti Xa IU (75-85 anti Xa IU/kg body weight per day). Patients included in group C had no major bleeding event (95% confidence interval, 0% to 6.6%), a significant improvement of the doppler ankle-brachial systolic pressure index (difference of 0.46 +/- 0.29, P=.017), and a higher rate of responders with regard to the puls status measured at the tibialis posterior arteries (66.7%) compared to groups A and B (46.7% and 54.5%, respectively, P=.086). The efficacy and safety of this dosage regimen in comparison to standard of care should be further substantiated in larger trials.
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Clin. Appl. Thromb. Hemost. · Jan 1999
Randomized Controlled Trial Clinical TrialEffects on hemostasis after two-year use of low dose combined oral contraceptives with gestodene or levonorgestrel.
We studied 67 healthy women who were randomly allocated to receive third generation gestodene (Gynera) or second generation levonorgestrel (Microgynon 30) combination of low-dose estrogen oral contraceptives (OCs) for their hemostatic effects over 2 years. Hemostatic changes were apparent within 3 months of OC use. Hematocrit (Hct) was not affected, but hemoglobin (Hb) concentration decreased by 18 months. ⋯ Activated protein C resistance (APCR) was negative in all subjects before and during OC use. The study indicated dynamic balance between coagulation and fibrinolysis with no endothelial activation. However, because some hemostatic markers showed wide fluctuations during OC use, a longer term study is warranted to investigate any adverse hemostatic changes that might enhance the risks of venous thromboembolism in Asian subjects known to be less prone to thrombosis.