Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01133002
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2010-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canadian Outpatient VTE Management Registry
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVERY
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.
\- 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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: