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CompletedNCT03404635MATHVTEUpdated Aug 7, 2020

Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

An observational study in Venous Thromboembolism, sponsored by Indiana University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.

Sponsored by Indiana University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Venous Thromboembolism
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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 (-).

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

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,300 participants (actual)
Patient registry
No

Groups and cohorts

  • Apixaban for VTE

    Drug: Apixaban

  • Rivaroxaban for VTE

    Drug: Rivaroxaban

Interventions

  • DrugApixaban

    Apixaban as standard of care for VTE

  • DrugRivaroxaban

    Rivaroxaban as standard of care for VTE

05

What researchers measure

Primary outcomes

  1. Number of re-hospitalization visits for VTE recurrence or bleeding

    Re-hospitalization for \> 24 hours due to VTE recurrence or bleeding

    Time frame: 30 days

06

Study locations

2 sites
  • Eskenazi Health System
    Indianapolis, Indiana 46202, United States
  • Indiana University Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
07

References and documents

Publications

  • Kline JA, Adler DH, Alanis N, Bledsoe JR, Courtney DM, d'Etienne JP, Diercks DB, Garrett JS, Jones AE, Mackenzie DC, Madsen T, Matuskowitz AJ, Mumma BE, Nordenholz KE, Pagenhardt J, Runyon MS, Stubblefield WB, Willoughby CB. Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007600. doi: 10.1161/CIRCOUTCOMES.120.007600. Epub 2021 Jun 21. PubMed 34148351 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03404635
Lead sponsor
Indiana University
Collaborators
Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals
Responsible party
Jeffrey Kline (Professor of Emergency Medicine, Indiana University) — Principal investigator
First posted
Jan 19, 2018
Start date
Aug 4, 2017
Primary completion
May 8, 2020
Completion
May 8, 2020
Last update
Aug 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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