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RECOVERY

Canadian Outpatient VTE Management Registry

Ensayo de Sanofi en Medical Prevention Therapy (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

915

previstos

Centros

1

Fin del objetivo primario

jun 2010

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en ago 2007.

Qué mide

Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites (Day 180 or end of anticoagulant therapy whichever comes first) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: \- To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings. Secondary Objective: * To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors. * To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE. * To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis: * Appropriate dosing of enoxaparin * Recommended duration of initial LMWH therapy * Adequate overlap of LMWH with vitamin K antagonists (VKA) * Recommended duration of longterm VKA * Frequency of use of LMWH monotherapy to treat cancer-related VTE * To access safety outcomes (including bleeding and recurrent VTE) * To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01133002), actualizada en ago 2010.