Clinical trial NCT02079584: Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
Official title: Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Patient Compliance
Target Specific Anticoagulant
Quality of Life
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.

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).

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 .

Eligibility criteria: 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%

Primary outcomes:
measure: Clot Recurrence
timeFrame: 5 years
measure: Bleeding
timeFrame: 5 years
Secondary outcomes:
measure: Adherence
timeFrame: 5 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
citation: 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.
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.
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.S104446. eCollection 2016.