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OpenTrials
Completed

NCT Number: NCT02079584

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

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46240, United States

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. Clot Recurrence

    Time frame: 5 years

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

  2. Bleeding

    Time frame: 5 years

    Bleeding that requires change in therapy

Secondary outcomes

  1. Adherence

    Time frame: 5 years

    Number of patients discontinuing anticoagulation in first 30 days and reason why

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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