Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

NCT03404635

Last updated date
Study Location
Eskenazi Health System
Indianapolis, Indiana, 46202, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients must be low risk, as defined by either A or B below:

A. The modified Hestia criteria:

- Systolic blood pressure > 100 mm Hg

- No thrombolysis needed

- No active bleeding

- SaO2 >94% while breathing room air

- Not already anticoagulated

- No more than two doses of IV narcotics in the emergency department

- Other medical or social reasons to admit

- Creatinine clearance >30mL/min

- Not pregnant, severe liver disease or heparin induced thrombocytopenia OR

B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).

All of the following must true:

- Age < 81 years

- No history of cancer

- No history of heart failure or chronic lung disease

- Pulse < 110 beats/min

- SBP > 99 mm Hg

- O2 sat >89%%

We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.

2. Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician
opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight
heparin injections or warfarin as prescribed for any condition)


- Sensitivity or contraindication to use of apixaban


- Troponin assay value, drawn as part of usual care and found to be positive, using
local standards


- High risk for hemorrhage defined by a score>1.5 using the method of Ruiz Gimenez.3
(Note that several criteria are already excluded by Hestia):


Recent major bleeding, 2 points Creatinine levels >1.2 mg/dl, 1.5 points Anemia, 1.5 points
Cancer, 1 point Clinically overt PE, 1 point Age >75 years, 1 point

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Advanced Information
Descriptive Information
Brief Title Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
Official Title Monotherapy Anticoagulation To Expedite Home Treatment of Venous
Brief Summary Prospective, multicenter observational study, of the effectiveness of a standard of care protocol implemented to enhance home treatment of VTE. Study population will be selected as part of usual care as eligible for home treatment. Study personnel will travel to participating institutions to qualify the sites, deliver a Powerpoint® lecture to introduce the protocol, meet and train site principal investigators, emergency physicians and research personnel on the implementation of the protocol as part of usual clinical care, and data collection methods for a quality assurance registry with plans to use the data collected in this registry in future publications. Follow-up will be 30 days using medical records and/or telephone interview to assess for primary outcomes of bleeding or VTE recurrence.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).
Condition Venous Thromboembolism
Intervention
  • Drug: Apixaban
    Apixaban as standard of care for VTE
  • Drug: Rivaroxaban
    Rivaroxaban as standard of care for VTE
Study Groups/Cohorts
  • Apixaban for VTE
    Intervention: Drug: Apixaban
  • Rivaroxaban for VTE
    Intervention: Drug: Rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 5, 2020)
1300
Original Estimated Enrollment
 (submitted: January 18, 2018)
850
Actual Study Completion Date May 8, 2020
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients must be low risk, as defined by either A or B below:

    A. The modified Hestia criteria:

    • Systolic blood pressure > 100 mm Hg
    • No thrombolysis needed
    • No active bleeding
    • SaO2 >94% while breathing room air
    • Not already anticoagulated
    • No more than two doses of IV narcotics in the emergency department
    • Other medical or social reasons to admit
    • Creatinine clearance >30mL/min
    • Not pregnant, severe liver disease or heparin induced thrombocytopenia OR

    B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).

    All of the following must true:

    • Age < 81 years
    • No history of cancer
    • No history of heart failure or chronic lung disease
    • Pulse < 110 beats/min
    • SBP > 99 mm Hg
    • O2 sat >89%%

    We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.

  2. Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.

Exclusion Criteria:

  • VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight heparin injections or warfarin as prescribed for any condition)
  • Sensitivity or contraindication to use of apixaban
  • Troponin assay value, drawn as part of usual care and found to be positive, using local standards
  • High risk for hemorrhage defined by a score>1.5 using the method of Ruiz Gimenez.3 (Note that several criteria are already excluded by Hestia):

Recent major bleeding, 2 points Creatinine levels >1.2 mg/dl, 1.5 points Anemia, 1.5 points Cancer, 1 point Clinically overt PE, 1 point Age >75 years, 1 point

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03404635
Other Study ID Numbers CV185-562
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Jeffrey Kline, Indiana University
Study Sponsor Indiana University
Collaborators
  • Bristol-Myers Squibb
  • Pfizer
  • Janssen Pharmaceuticals
Investigators Not Provided
PRS Account Indiana University
Verification Date August 2020