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. · Apr 2003
Ineffectiveness of measuring routine vital signs in adult inpatients with deep venous thrombosis.
The purpose of this study was to evaluate the benefit, if any, of routine monitoring of vital signs on clinical outcomes in hospitalized patients with deep venous thrombosis (DVT). One hundred forty-nine patients with DVT included in this study were categorized into two groups: those that underwent measurement of vital signs every 6 hours or those that had vital signs measured every 8 hours. Vital signs included pulse, blood pressure, respiratory rate, and temperature. ⋯ Similarly, more frequent vital sign evaluation did not result in a statistically significant difference in survival, progression of disease, nor did it predict the disposition of the patient. These results suggest that present frequency of measurement of vital signs is not cost or time effective because they do not result in a favorable outcome, length of stay, or disposition. The study further serves to highlight the need for an individualized assessment of vital sign measurement, because this will also lead to a more efficient allocation of hospital resources.
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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. · Jan 2003
Global anticoagulant effects of a synthetic anti-factor Xa inhibitor (DX-9065a): implications for interventional use.
Heparin has been conventionally used as an anticoagulant for medical and surgical indications. Because factor Xa is an essential component of the prothrombinase complex and leads to the generation of thrombin, its inhibition has become a focus of newer antithrombotic drug development. The in vitro anticoagulant profile of DX-9065a, a synthetic direct factor Xa inhibitor, was studied using activated clotting time assay, thrombelastography, and global clotting tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT), diluted aPTT, Heptest, Heptest-HI, dilute Russell's viper venom time (dRVVT), thrombin time, ecarin clotting time, and amidolytic anti-Xa assay. ⋯ DX-9065a exhibited a concentration-dependent prolongation of the PT, aPTT, diluted aPTT, Heptest, dRVVT, and reached the clotting times of 51.6, 132, 193, 47.9, 129.9 seconds, respectively, at a final concentration of 12.5 microgram/mL; compared to a control value of 10.6, 30.2, 41.9, 14, 32.2 seconds, respectively. DX-9065a did not affect the ecarin clotting time and thrombin time at concentrations up to 12.5 microgram/mL. Because DX-9065a prolonged the dRVVT, this may impact diagnostic screening of patients with systemic lupus erythematosus.
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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. · Oct 2002
Effects of a synthetic factor Xa inhibitor (JTV-803) on various laboratory tests.
Synthetic direct inhibitors of factor Xa are capable of prolonging the global anticoagulant assay times in a concentration-dependent fashion. The relative degree of thrombin generation inhibition at an equivalent prolongation is not similar to the results observed with heparins and oral anticoagulant drugs. In addition, the direct factor Xa inhibitors prolong the Russell's viper venom test (RWT) and Heptest clotting times. ⋯ Similar results were observed when different aPTT reagents were studied. In the anti-Xa assay, modification of the incubation time was employed to extend the proper sensitivity range. These studies warrant further investigation to understand the mechanism of action of factor Xa inhibitors.