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 2011
ReviewNew and generic anticoagulants and biosimilars: safety considerations.
The recent health care changes and approval of a generic low-molecular-weight heparin (LMWH) by the US Food and Drug Administration (FDA) merit a review of the facts regarding the new and generic anticoagulants. Fatal hypotension from anaphylactoid type reactions following heparin administration was responsible for more than 149 deaths all over the world. Researchers detected a heparin-like semisynthetic contaminant, over-sulfated chondroitin sulfate (OSCS), that appeared to be intentional. ⋯ Therefore, monitoring assays are not being developed and there is no antidote to reverse bleeding. In addition, there are concerns about reproducibility, product variation, and quality. In conclusion, although the generic LMWHs and newer anticoagulants may appear to be effective for qualified indications, their safety remains to be a concern.
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Clin. Appl. Thromb. Hemost. · Feb 2011
Clinical TrialTissue factor pathway inhibitor and P-selectin as markers of sepsis-induced non-overt disseminated intravascular coagulopathy.
Inflammation and coagulation occur concomitantly in sepsis. Thrombin activates platelet that leads to P-selectin translocation, which upregulate tissue factor (TF) generation. Tissue factor pathway inhibitor (TFPI) is an anticoagulant that modulates coagulation induced by TF. ⋯ Sequential Organ Failure Assessment score was correlated with DIC score and other hemostatic markers in patients with overt DIC. To improve the outcome of patients with DIC, there is a need to establish more diagnostic criteria for non-overt-DIC. Plasma levels of TFPI and P-selectin may be helpful in this respect.
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Clin. Appl. Thromb. Hemost. · Feb 2011
Case ReportsRecurrent pulmonary embolism associated with a hemostatic drug: tranexamic acid.
Tranexamic acid (TA) used in a variety of conditions associated with bleeding has been associated with potential thrombotic side effects such as formation of thrombi and pulmonary embolism (PE). We describe a case of a woman with chronic hemoptysis and a history of PE, who recently used TA as a prophylactic measure, which could have resulted in a new episode of PE. Tranexamic acid probably played a contributory role in the development of her second PE.
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Clin. Appl. Thromb. Hemost. · Dec 2010
Limited utility of a rapid quantitative enzyme-linked fluorescent assay for the D-dimer in the diagnosis of overt disseminated intravascular coagulation.
The role of quantitative D-dimer assay in screening for and diagnosing overt disseminated intravascular coagulation (DIC), conventionally diagnosed by the International Society of Thrombosis and Haemostasis' (ISTH) score, was evaluated. Of patients with clinical conditions associated with overt DIC, 142 with ISTH scores ≥5 (compatible with overt DIC) and 61 with ISTH scores <5 (suggestive of nonovert DIC) underwent the quantitative D-dimer assay. Accuracy indices, receiver operating characteristic (ROC) curve-derived cutoffs, and areas under curve were compared. ⋯ Extensive overlap between groups at this cutoff reduced diagnostic utility. Lowered cutoffs increased sensitivity (eg, 91.5% at 1000 ng/mL) but diminished specificity (59%), limiting use of screening. In conclusion, the quantitative D-dimer as a stand-alone assay has a limited role in diagnosis of overt DIC.
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Clin. Appl. Thromb. Hemost. · Oct 2010
ReviewState-of-the-art review: Hemostats, sealants, and adhesives II: Update as well as how and when to use the components of the surgical toolbox.
The goal of this submission is to describe how and when to best use hemostats, sealants, and adhesives as well as to compare their characteristics and to update the surgical toolbox with respect to any new products approved by the Food and Drug Administration (FDA) as of this date (November 2009). The materials will be presented in 3 major groups each containing specific categories: (1) hemostats; mechanical, active, flowable, and fibrin sealant, (2) sealants; fibrin sealant, polyethylene glycol polymer, and albumin and glutaraldehyde, (3) adhesives; cyanoacrylate, albumin and glutaraldehyde, and fibrin sealant. ⋯ Recommendations with respect to how and when to best use these materials will be presented. A review of the recent literature is also provided with respect to the most recent uses of these materials in specific surgical specialties.