Venous ThromboembolismNCT02079584
Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
An observational study of Venous Thromboembolism, run by Indiana University at 1 site in United States.
Trial summary
The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 14 Aug 2014
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.
Who may be able to join
- DVT or PE diagnosed on imaging:
- Systolic always>100 mm Hg in absence of history of low blood pressure
- No contraindication to anticoagulation treatment (active bleeding or high risk postoperative status, creatinine clearance < 30 ml/min, history of heparin induced thrombocytopenia or warfarin skin necrosis);
- No other medical condition requiring hospital treatment (sepsis, new or decompensated existing organ failure, intractable pain);
- No social condition requiring hospital treatment (homelessness with history of non-adherence to treatment, suspected neglect or abuse, incarceration, untreated psychosis, severe alcohol or drug dependency);
- No coagulopathy or current anticoagulant resulting in an INR>1.7, or thrombocytopenia (platelet count < 50,000/uL);
- No need for supplemental oxygen (no respiratory distress and pulse ox always >94%)
Who cannot join
- If active cancer, POMPE-C <6%
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. The investigators hypothesize that patients will have a relatively low rate of adverse events and higher adherence than has been reported historically for warfarin treatment. Patients will be scheduled for follow up care with one of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital, Eskenazi Health Services and the Baylor University Medical Center (Dallas, TX) after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT).
Read the detailed description
Information will be obtained from the patient medical records, past medical history, physical examination at initial outpatient clinic visit 30 days (+/- 14 days) and 6 months or 180 days (+/- 14 days) post diagnosis or start of treatment, then annual follow ups for up to 5 years. The data will be collected and stored in a database, the IU RedCap database system will be used to develop a database and store information .
- Conditions
- Venous Thromboembolism
- Keywords
- Patient Compliance, Target Specific Anticoagulant, Quality of Life
- Medical subject headings
- Venous Thromboembolism, Patient Compliance
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 |
|---|---|---|
| Warfarin | A study group taken from existing anticoagulant clinics treated with warfarin. | |
| Rivaroxaban | A group seen in the rivaroxaban clinic under study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clot Recurrence
The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Measured: 5 years
Bleeding
Bleeding that requires change in therapy
Measured: 5 years
Secondary outcomes (1)
Adherence
Number of patients discontinuing anticoagulation in first 30 days and reason why
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2013
- Primary completion14 Aug 2014
- Study completion14 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079584
- Sponsor's protocol ID
- fwa00003543
- Status last verified
- Jan 2022
- First submitted
- 4 Mar 2014
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beam DM, Kahler ZP, Kline JA. Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis. Acad Emerg Med. 2015 Jul;22(7):788-95. doi: 10.1111/acem.12711. Epub 2015 Jun 25.
PubMed 26113241Kahler ZP, Beam DM, Kline JA. Cost of Treating Venous Thromboembolism With Heparin and Warfarin Versus Home Treatment With Rivaroxaban. Acad Emerg Med. 2015 Jul;22(7):796-802. doi: 10.1111/acem.12713. Epub 2015 Jun 25.
PubMed 26111453Kline JA, Kahler ZP, Beam DM. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance. Patient Prefer Adherence. 2016 Apr 15;10:561-9. doi: 10.2147/PPA.S104446. eCollection 2016.
PubMed 27143861
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
- ClinicalTrials.gov ID
- NCT02079584
- Acronym / sponsor ID
- fwa00003543
- Conditions
- Venous Thromboembolism
- Keywords
- Patient Compliance, Target Specific Anticoagulant, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 14 Aug 2014 (actual)
- Study completion
- 14 Aug 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- 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.
The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. The investigators hypothesize that patients will have a relatively low rate of adverse events and higher adherence than has been reported historically for warfarin treatment. Patients will be scheduled for follow up care with one of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital, Eskenazi Health Services and the Baylor University Medical Center (Dallas, TX) after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT).
Detailed description
Information will be obtained from the patient medical records, past medical history, physical examination at initial outpatient clinic visit 30 days (+/- 14 days) and 6 months or 180 days (+/- 14 days) post diagnosis or start of treatment, then annual follow ups for up to 5 years. The data will be collected and stored in a database, the IU RedCap database system will be used to develop a database and store information .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | – | –A study group taken from existing anticoagulant clinics treated with warfarin. |
| Rivaroxaban | – | –A group seen in the rivaroxaban clinic under study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.
Key inclusion criteria (7 listed)
- DVT or PE diagnosed on imaging:
- Systolic always>100 mm Hg in absence of history of low blood pressure
- No contraindication to anticoagulation treatment (active bleeding or high risk postoperative status, creatinine clearance < 30 ml/min, history of heparin induced thrombocytopenia or warfarin skin necrosis);
- No other medical condition requiring hospital treatment (sepsis, new or decompensated existing organ failure, intractable pain);
- No social condition requiring hospital treatment (homelessness with history of non-adherence to treatment, suspected neglect or abuse, incarceration, untreated psychosis, severe alcohol or drug dependency);
Key exclusion criteria (1 listed)
- If active cancer, POMPE-C <6%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clot Recurrence
Time frame: 5 years
The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Bleeding
Time frame: 5 years
Bleeding that requires change in therapy
1 secondary outcome
Adherence
Time frame: 5 years
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 11 Feb 2022.
- Background: PubMed 26113241Beam DM, Kahler ZP, Kline JA. Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis. Acad Emerg Med. 2015 Jul;22(7):788-95. doi: 10.1111/acem.12711. Epub 2015 Jun 25.
- Background: PubMed 26111453Kahler ZP, Beam DM, Kline JA. Cost of Treating Venous Thromboembolism With Heparin and Warfarin Versus Home Treatment With Rivaroxaban. Acad Emerg Med. 2015 Jul;22(7):796-802. doi: 10.1111/acem.12713. Epub 2015 Jun 25.
- Results publication: PubMed 27143861Kline JA, Kahler ZP, Beam DM. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance. Patient Prefer Adherence. 2016 Apr 15;10:561-9. doi: 10.2147/PPA.S104446. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thromboembolism, run by Indiana 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 7 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 11 Feb 2022. 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?
Clot Recurrence (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT02079584, which also lists 3 linked publications.
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 11 Feb 2022.