Venous Thromboembolic DiseaseNCT04818151
Anticoagulation Strategies for Acute Venous Thromboembolism in Patients With End-Stage Renal Disease Using USRDS Data
An observational study of Venous Thromboembolic Disease and Kidney Failure, Chronic, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolic Disease, Kidney Failure, Chronic
- What is being tested?
- Warfarin and Apixaban
- How many people
- 14,914 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in USRDS dataset from 2009-2018 with ESRD and VTE
Who may be able to join
- ESRD on dialysis with acute VTE
Who cannot join
- Anticoagulation for non-VTE indication
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The investigators will perform a retrospective cohort analysis using USRDS data from 2014 through 2018 and a descriptive serial cross-sectional analysis using USRDS data from 2009 through 2018 to evaluate the investigators' aims. USRDS data will be utilized to address all the research aims.
Primary Objective To compare rates of major bleeding attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary safety outcome will be rates of major bleeding within 6 months of VTE diagnosis as defined by Cunningham, which is a standardized definition of major bleeding that can be derived from administrative data and is based on clinical bleeding definitions from a number of clinical trials. A secondary safety outcome will be gastrointestinal bleeding within 6 months of VTE diagnosis.
Secondary Objectives To describe contemporary anticoagulation strategies to treat acute VTE in ESRD patients and changes over the last decade The investigators will report rates of use of anticoagulation strategies [warfarin, low molecular weight heparin (LMWH), and DOACs (apixaban, edoxaban, rivaroxaban, and dabigatran)] in this ESRD population. The investigators will examine rates of these strategies by year to examine changes in adoption of various strategies over time as DOACs have become available for VTE treatment.
To compare rates of recurrent VTE attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary outcome will be recurrent VTE within 6 months of VTE diagnosis. All-cause mortality within 6 months of VTE diagnosis will be evaluated as an exploratory endpoint.
To compare healthcare resource utilization from 15 days before to 90 days after first prescription date attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary outcome will be total inpatient days from 15 days before to 90 days after first prescription date. In addition to total inpatient days, the investigators will also compare emergency department (ED) utilization after initiation of anticoagulation across treatment strategies. By incorporating 15 days prior to first prescription date, the investigators will capture hospitalization days that were associated with the index VTE diagnosis, given that the first anticoagulation prescription would likely be written at the time of hospital discharge for those patients who are hospitalized.
- Keywords
- Anticoagulation, Apixaban, Warfarin, Heparin, Bleeding, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients with VTE treated with warfarin | Warfarin as primary treatment of VTE Receives: Drug: Warfarin | |
| ESRD patients with VTE treated with apixaban | Apixaban as primary treatment of VTE Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding occurrence
Number of bleeding occurrences.
Measured: 3 months
Recurrent thrombosis occurrence
Number of recurrent thrombosis occurrences.
Measured: 3 months
Secondary outcomes (1)
Days in acute care
Number of hospital days/ED utilization.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14,914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Daniel J Brotman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818151
- Sponsor's protocol ID
- IRB00272929
- Other IDs
- CV185-804
- Status last verified
- Jul 2021
- First submitted
- 24 Mar 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04818151
- Acronym / sponsor ID
- IRB00272929
- Keywords
- Anticoagulation, Apixaban, Warfarin, Heparin, Bleeding, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,914 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will perform a retrospective cohort analysis using USRDS data from 2014 through 2018 and a descriptive serial cross-sectional analysis using USRDS data from 2009 through 2018 to evaluate the investigators' aims. USRDS data will be utilized to address all the research aims.
Primary Objective To compare rates of major bleeding attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary safety outcome will be rates of major bleeding within 6 months of VTE diagnosis as defined by Cunningham, which is a standardized definition of major bleeding that can be derived from administrative data and is based on clinical bleeding definitions from a number of clinical trials. A secondary safety outcome will be gastrointestinal bleeding within 6 months of VTE diagnosis.
Secondary Objectives To describe contemporary anticoagulation strategies to treat acute VTE in ESRD patients and changes over the last decade The investigators will report rates of use of anticoagulation strategies [warfarin, low molecular weight heparin (LMWH), and DOACs (apixaban, edoxaban, rivaroxaban, and dabigatran)] in this ESRD population. The investigators will examine rates of these strategies by year to examine changes in adoption of various strategies over time as DOACs have become available for VTE treatment.
To compare rates of recurrent VTE attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary outcome will be recurrent VTE within 6 months of VTE diagnosis. All-cause mortality within 6 months of VTE diagnosis will be evaluated as an exploratory endpoint.
To compare healthcare resource utilization from 15 days before to 90 days after first prescription date attributable to initiation of treatment with apixaban relative to warfarin among patients with ESRD and acute VTE The primary outcome will be total inpatient days from 15 days before to 90 days after first prescription date. In addition to total inpatient days, the investigators will also compare emergency department (ED) utilization after initiation of anticoagulation across treatment strategies. By incorporating 15 days prior to first prescription date, the investigators will capture hospitalization days that were associated with the index VTE diagnosis, given that the first anticoagulation prescription would likely be written at the time of hospital discharge for those patients who are hospitalized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD patients with VTE treated with warfarin | – | Drug: WarfarinWarfarin as primary treatment of VTE |
| ESRD patients with VTE treated with apixaban | – | Drug: ApixabanApixaban as primary treatment of VTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in USRDS dataset from 2009-2018 with ESRD and VTE
Key inclusion criteria (1 listed)
- ESRD on dialysis with acute VTE
Key exclusion criteria (1 listed)
- Anticoagulation for non-VTE indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinWarfarin treatment for VTE | Drug | ESRD patients with VTE treated with warfarin |
| ApixabanApixaban treatment for VTE | Drug | ESRD patients with VTE treated with apixaban |
Primary outcome
Bleeding occurrence
Time frame: 3 months
Number of bleeding occurrences.
Recurrent thrombosis occurrence
Time frame: 3 months
Number of recurrent thrombosis occurrences.
1 secondary outcome
Days in acute care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Brotman, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease and Kidney Failure, Chronic, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding occurrence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.