Trial record 9 of 427 for:    Open Studies | "Anticoagulants"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Jeffrey Kline, Indiana University
ClinicalTrials.gov Identifier:
NCT02079584
First received: March 4, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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. We 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 Wishard Health Services after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT). We 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 we hypothesize to be important to understand the causes of non-adherence. To better quantify the economic impact, we will also perform a cost effectiveness analysis with no comparator, meaning we will tabulate the cost of care for each patient enrolled using variable costs from a UB92 report for each patient.


Condition
Venous Thromboembolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Clot Recurrence [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.

  • Adherence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rivaroxaban is anticipated to be equal in adherence to warfarin given the predictability of dosing.


Secondary Outcome Measures:
  • Cost [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will assess costs of medication and medical bills to the patients.

  • Patient Satisfaction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will assess patient satisfaction with treatment.


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 350
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Warfarin
A study group taken from existing anticoagulant clinics treated with warfarin.
Rivaroxaban
A group seen in the rivaroxaban clinic under study.

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 .

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.

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%

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079584

Contacts
Contact: Jeffrey A Kline, MD 3176700541 jefkline@iu.edu
Contact: Zachary P Kahler, MD 5203700955 zkahler@iu.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46240
Contact: Jeffrey A Kline, MD         
Principal Investigator: Jeffrey A Kline, MD         
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Jeffrey Kline, Vice Chair of Research, Indiana University
ClinicalTrials.gov Identifier: NCT02079584     History of Changes
Other Study ID Numbers: fwa00003543
Study First Received: March 4, 2014
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Patient Compliance
Target Specific Anticoagulant
Quality of Life

Additional relevant MeSH terms:
Anticoagulants
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014