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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02079584

Enrollment

Registered

2014-03-06

Start date

2013-03-31

Completion date

2014-08-14

Last updated

2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Patient Compliance, Target Specific Anticoagulant, Quality of Life

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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%

Design outcomes

Primary

Measure	Time frame	Description
Clot Recurrence	5 years	The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Bleeding	5 years	Bleeding that requires change in therapy

Secondary

Measure	Time frame	Description
Adherence	5 years	Number of patients discontinuing anticoagulation in first 30 days and reason why

Countries

United States

Outcome results