Clinical trial NCT01133002: Canadian Outpatient VTE Management Registry
Official title: National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Prevention Therapy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with objectively confirmed symptomatic VTE treated at approximately 15 outpatient clinics across Canada which use enoxaparin for the treatment of acute VTE.

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.


Eligibility criteria: Inclusion criteria:

* Objectively confirmed VTE
* Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE:
* Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study
* Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study.

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.

Primary outcomes:
measure: Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
Secondary outcomes:
measure: Patient characteristics associated with different patterns of VTE management and enoxaparin use
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008)
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: Incidence of bleeding events and episodes of recurrent VTE
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
measure: 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)
timeFrame: Day 180 or end of anticoagulant therapy whichever comes first
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Medical Affairs
role: STUDY_DIRECTOR
References: