NCT03404635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

December 19, 2017

Last Update Submit

August 5, 2020

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Number of re-hospitalization visits for VTE recurrence or bleeding

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

    30 days

Study Arms (2)

Apixaban for VTE

Drug: Apixaban

Rivaroxaban for VTE

Drug: Rivaroxaban

Interventions

ApixabanDRUG

Apixaban as standard of care for VTE

Apixaban for VTE
RivaroxabanDRUG

Rivaroxaban as standard of care for VTE

Rivaroxaban for VTE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eskenazi Health System

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 34148351DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixabanRivaroxaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 19, 2018

Study Start

August 4, 2017

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations

US(2)