Journal of thrombosis and thrombolysis
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J. Thromb. Thrombolysis · Aug 2006
Randomized Controlled TrialExtended-duration thromboprophylaxis in acutely ill medical patients with recent reduced mobility: methodology for the EXCLAIM study.
Venous thromboembolism (VTE) is a significant cause of mortality and morbidity in medical patients. Although thromboprophylaxis with enoxaparin reduces the risk of VTE in these patients, the optimal duration of therapy is not currently known. The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin with the standard regimen of enoxaparin in acutely ill medical patients with recent reduced mobility. ⋯ The EXCLAIM study is designed to show the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin in acutely ill medical patients with recent reduced mobility, which may potentially lead to a reduction in the incidence of late VTE events in these patients. The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study, involving 4,726 acutely ill medical patients with recent reduced mobility, is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using 40 mg once daily enoxaparin (38 +/- 4 days) with the standard regimen for enoxaparin (40 mg once daily for 10 +/- 4 days). The objective of this study is to demonstrate that the extended-duration enoxaparin regimen is an effective and safe thromboprophylaxis regimen out of hospital.
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J. Thromb. Thrombolysis · Aug 2006
Host-guest composites for induced hemostasis and therapeutic healing in traumatic injuries.
The United States military currently outfits our soldiers with a zeolite-based hemostatic agent (HA) that is applied directly onto a traumatic wound to induce hemostasis and prevent loss of life from exsanguination. The goals of this work were to identify and implement strategies to attenuate a tissue burning side effect associated with the HA, resulting from a large release of heat upon hydration, without adversely affecting the wound healing properties. Five ion exchanged derivatives of the parent HA were prepared and characterized with regard to their material and thermal properties, in vitro hemostatic efficacy, and antibacterial activity. ⋯ Two strategies for reducing the large amount of heat released by a zeolite-based HA during application have been described and quantified: (1) ion exchange and (2) prehydration. Five ion-exchanged derivatives of the original HA have been prepared and assayed for hemostatic efficacy both in vitro, by TEG, and in vivo, by clinical swine trials. Contact activation coagulation rates, alpha, were found to increase with the amount of heat released by the HA. In Vitro clot induction time, R, and HA surface area have been identified as predictors of in vivo hemostatic performance. A proposed rationale for selecting hemostatic materials based on these parameters will likely reduce the quantity of experiments involving animals, and the associated labor and capital costs, necessary to test a new HA. A method for incorporating antibacterial activity against gram negative P. aeruginosa into the Ag-exchanged formulation of zeolite LTA-5A has been described and substantiated.