Anticoagulation Strategies for Acute Venous Thromboembolism in Patients With End-Stage Renal Disease Using USRDS Data

NCT04818151 | Completed FDA Drug

• 2 other identifiers: IRB00272929CV185-804
• Study Type: observational
• Target: 14,914
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolic Disease; Kidney Failure, Chronic

Keywords

Anticoagulation; Apixaban; Warfarin; Heparin; Bleeding; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Bleeding occurrence

  Number of bleeding occurrences.

  3 months

• Recurrent thrombosis occurrence

  Number of recurrent thrombosis occurrences.

  3 months

Secondary Outcomes (1)

• Days in acute care

  3 months

Study Arms (2)

ESRD patients with VTE treated with warfarin

Warfarin as primary treatment of VTE

Drug: Warfarin

ESRD patients with VTE treated with apixaban

Apixaban as primary treatment of VTE

Drug: Apixaban

Interventions

Warfarin DRUG

Warfarin treatment for VTE

ESRD patients with VTE treated with warfarin

Apixaban DRUG

Apixaban treatment for VTE

ESRD patients with VTE treated with apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in USRDS dataset from 2009-2018 with ESRD and VTE

You may qualify if:

• ESRD on dialysis with acute VTE

You may not qualify if:

• Anticoagulation for non-VTE indication

Sponsors & Collaborators

• Johns Hopkins University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hemorrhage

Interventions

Warfarin; apixaban

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Daniel J Brotman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

US (1)