Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT03404635
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03404635
Study Brief:
Protocol Section:
NCT03404635