Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant

NCT02079584 | Completed

• 1 other identifier: fwa00003543
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Venous Thromboembolism

Keywords

Patient Compliance; Target Specific Anticoagulant; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Clot Recurrence

  The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.

  5 years

• Bleeding

  Bleeding that requires change in therapy

  5 years

Secondary Outcomes (1)

• Adherence

  5 years

Study Arms (2)

Warfarin

A study group taken from existing anticoagulant clinics treated with warfarin.

Rivaroxaban

A group seen in the rivaroxaban clinic under study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.

You may qualify if:

• 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%)

You may not qualify if:

• \- If active cancer, POMPE-C \<6%

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46240, United States

Location

Related Publications (3)

• 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.

  PMID: 26113241 BACKGROUND

• Kahler 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.

  PMID: 26111453 BACKGROUND

• Kline 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.

  PMID: 27143861 RESULT

Biospecimen

Retention: NONE RETAINED

A blood sample will be obtained at the initial outpatient visit within 30 days (+/- 14 days) post diagnosis and/or start of treatment and at the 180 day (+/- 14 days) follow up post treatment visit and at each annual visit for up to 5 years.

MeSH Terms

Conditions

Venous Thromboembolism; Patient Compliance

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: March 1, 2013
• Primary Completion: August 14, 2014
• Study Completion: August 14, 2014
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)