A. 510(k) Number: k093974 B. Purpose for Submission: New Device C. Measurand: Factor II (FII) (Prothrombin) Factor V (FV) Leiden 5, 10 methylenetetrahydrofolate reductase (MTHFR) D. Type of Test: Qualitative genotyping test for single nucleotide polymorphism detection E. Applicant: Osmetech Molecular Diagnostics F. Proprietary and Established Names: eSensor® Thrombophilia Risk Test eSensor® FII...

conclusions: we determined a significant higher frequency of protein s deficiency in patients with rpl compared with controls. but the frequency of protein c deficiency and the frequency of two common thrombophilic mutations (factor v leiden and prothrombin g20210a), were not significantly different between patients with recurrent miscarriage and healthy women. results: the mean functional acti...

OBJECTIVE Budd-Chiari syndrome is a multifactorial disease in which several prothrombotic disorders may predispose patients to the development of thrombosis at this uncommon location (hepatic veins). The aim of this study was to determine the prevalence and characteristics of inherited thrombophilia in Egyptian Budd-Chiari syndrome patients. METHODS The study included 47 Budd-Chiari syndrome ...

OBJECTIVE To investigate the prevalence of currently recognised inherited prothrombotic states in a population of children with arterial stroke. METHODS Children with arterial stroke presenting to a tertiary level paediatric neurology centre between 1990 and 1996 were investigated for inherited prothrombotic states. RESULTS Sixty seven children with arterial stroke were investigated. Abnorm...

We report a patient who died as a result of heparin induced thrombocytopenia (HIT) and arterial thromboses following cardiac surgery. The onset was three days after exposure to low molecular weight heparin on the eighth postoperative day. The patient was heterozygous for the factor V Leiden mutation. We have reviewed 15 patients previously diagnosed as HIT on clinical and laboratory criteria an...

BACKGROUND AND OBJECTIVES The purpose of this study was to assess the incidence of central venous catheter (CVC)-related thrombosis and the contribution of two common inherited coagulation disorders (factor V Leiden, prothrombin G20210A mutation) to this complication in a large hospital population. DESIGN AND METHODS In a prospective setting, patients were assessed daily for signs and symptom...

Systemic lupus erythematosus (SLE) is associated with an increased risk of venous (VTE) and arterial thromboembolism (ATE). Lupus anticoagulant (LA) and anticardiolipin antibodies (ACAs) are established risk factors. We assessed the contribution of deficiencies of antithrombin, protein C, total protein S, factor V Leiden, the prothrombin G20210A mutation and APC resistance, either alone or in v...

Systemic lupus erythematosus (SLE) is associated with an increased risk of venous (VTE) and arterial thromboembolism (ATE). Lupus anticoagulant (LA) and anticardiolipin antibodies (ACAs) are established risk factors. We assessed the contribution of deficiencies of antithrombin, protein C, total protein S, factor V Leiden, the prothrombin G20210A mutation and APC resistance, either alone or in v...

prevalence of the thrombosis in the childhood increases in recent years. In adulthood, incidence of thrombosis is 1% and in childhood the incidence is 1/100,000 per year.1 In addition to its increasing prevalence in the childhood, as thrombosis is an important reason in the childhood morbidity and mortality, the studies on thrombosis gradually increase. It is known that the general mutations in...

BACKGROUND Oral estrogen increases the risk of venous thromboembolism (VTE) in postmenopausal women, particularly in those with a prothrombotic mutation. Transdermal estrogen may be safe with respect to VTE. We investigated the impact of the route of estrogen administration on the association between a prothrombotic mutation (factor V Leiden or prothrombin G20210A mutation) and VTE risk. METH...