Canadian Outpatient VTE Management Registry
- Conditions
- Medical Prevention Therapy
- Registration Number
- NCT01133002
- Lead Sponsor
- Sanofi
- Brief Summary
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:
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 915
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment 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
- Secondary Outcome Measures
Name Time Method Incidence of bleeding events and episodes of recurrent VTE 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 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) Day 180 or end of anticoagulant therapy whichever comes first 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)
Patient characteristics associated with different patterns of VTE management and enoxaparin use Day 180 or end of anticoagulant therapy whichever comes first 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇦Laval, Canada