Overview

This trial is active, not recruiting.

Condition venous thromboembolism
Sponsor Indiana University
Start date March 2013
End date March 2016
Trial size 350 participants
Trial identifier NCT02079584, fwa00003543

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 or Eskenazi Health Services after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT). The investigators will collect information for a registry and a database will be developed and blood specimens will be obtained at each follow up visit for analysis and storage for possible use related to this treatment and research or study at a later date. Questionnaires will be administered to collect variables that the investigators hypothesize to be important to understand the causes of non-adherence. To better quantify the economic impact, the investigators will also perform a cost effectiveness analysis with no comparator, meaning the investigators will tabulate the cost of care for each patient enrolled using variable costs from a UB92 report for each patient.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
A study group taken from existing anticoagulant clinics treated with warfarin.
A group seen in the rivaroxaban clinic under study.

Primary Outcomes

Measure
Clot Recurrence
time frame: 5 years
Adherence
time frame: 5 years

Secondary Outcomes

Measure
Cost
time frame: 5 years
Patient Satisfaction
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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%

Additional Information

Official title Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
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 . 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. A SF 36 questionnaire will be administered at 30 days (+/- 14 days) post diagnosis and/or start of treatment and at the 180 day (+/- 14 days) follow up post treatment visit.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Indiana University.