Clinical trial NCT03404635: Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
Official title: Monotherapy Anticoagulation To Expedite Home Treatment of Venous
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Pfizer
name: Janssen Pharmaceuticals
First posted: 2018-01-19
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 (-).

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.


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

Primary outcomes:
measure: Number of re-hospitalization visits for VTE recurrence or bleeding
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
References:
citation: 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.