Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/2/2018 |
| Start Date: | March 2013 |
| End Date: | March 2021 |
| Contact: | Jeffrey A Kline, MD |
| Email: | jefkline@iu.edu |
| Phone: | 3176700541 |
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).
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).
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 .
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 .
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%
We found this trial at
1
site
425 University Blvd.
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Jeffrey A Kline, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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