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Primary 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTE management registry | Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin | Day 180 or end of anticoagulant therapy whichever comes first | |
| Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin | Day 180 or end of anticoagulant therapy whichever comes first | |
| Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment | Day 180 or end of anticoagulant therapy whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics associated with different patterns of VTE management and enoxaparin use | Analysis of patient characteristics associated with different patterns of VTE management and enoxaparin use, such as age, weight, creatinine clearance, co-morbid disease, VTE characteristics, concomitant use of other pharmacological and non-pharmacological treatment of the VTE, concomitant use of other non-VTE related therapies |
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Inclusion criteria:
Exclusion criteria:
- Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Patients with objectively confirmed symptomatic VTE treated at approximately 15 outpatient clinics across Canada which use enoxaparin for the treatment of acute VTE.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Laval | Canada |
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| Day 180 or end of anticoagulant therapy whichever comes first |
| Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008) | Day 180 or end of anticoagulant therapy whichever comes first |
| Incidence of bleeding events and episodes of recurrent VTE | Day 180 or end of anticoagulant therapy whichever comes first |
| To tabulate VTE-related resources utilized during the study period and compare resource utilization in patients treated vs not treated as per Concensus Guidelines (ACCP 2008) | VTE-related resources utilized during the study period, including cost of VTE and its treatment (e.g. duration of hospital stay, drug costs, costs related to bleeding such as transfusions, costs of recurrent VTE) and compare resource utilization in patients treated vs. not treated as recommended by Concensus Guidelines (ACCP 2008) | Day 180 or end of anticoagulant therapy whichever comes first |