Kidney Failure, Chronic Clinical Trial
Official title:
Anticoagulation Strategies for the Treatment of Acute Venous Thromboembolism in Medicare Fee For-Service Patients With End-Stage Renal Disease Using USRDS Data
Verified date | July 2021 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with end stage renal disease (ESRD) are at significantly increased risk of thrombosis and bleeding relative to those with normal renal function which makes anticoagulation particularly challenging. Further, ESRD patients undergoing initiation of anticoagulation for acute VTE are often kept in the hospital for heparin "bridging" which may lead to a protracted length-of-stay (LOS) and may place patients at risk for hospital-associated complications. The advent of direct oral anticoagulants (DOACs) has offered physicians choices in the management of venous thromboembolism (VTE). However, evidence suggests that rivaroxaban and dabigatran are associated with a higher risk of bleeding in ESRD patients. In contrast, research suggests that apixaban may be safer in patients with ESRD, and recent evidence suggests lower bleeding rates in ESRD patients treated for atrial fibrillation with apixaban compared to those treated with warfarin. However, to date, no large national cohort studies have examined the safety, effectiveness, and healthcare utilization of apixaban in patients with ESRD who have acute VTE. The investigators propose to use the Standard Analytic Files from the United States Renal Data System (USRDS) for years 2014 through 2018 to evaluate the safety, effectiveness, and healthcare utilization of ESRD patients initiated on apixaban compared to those initiated on warfarin (following heparin) to treat acute VTE.
Status | Completed |
Enrollment | 14914 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ESRD on dialysis with acute VTE Exclusion Criteria: - Anticoagulation for non-VTE indication |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding occurrence | Number of bleeding occurrences. | 3 months | |
Primary | Recurrent thrombosis occurrence | Number of recurrent thrombosis occurrences. | 3 months | |
Secondary | Days in acute care | Number of hospital days/ED utilization. | 3 months |
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