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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079584
• Other study ID #: fwa00003543
• Status: Completed
• Start date: March 2013
• Est. completion date: August 14, 2014

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 14, 2014
• Est. primary completion date: August 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion:

• 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%)

Exclusion:

• If active cancer, POMPE-C <6%

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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.S10444 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clot Recurrence	The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.	5 years
Primary	Bleeding	Bleeding that requires change in therapy	5 years
Secondary	Adherence	Number of patients discontinuing anticoagulation in first 30 days and reason why	5 years