Status:
COMPLETED
Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Bristol-Myers Squibb
Pfizer
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
August 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2020
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT03404635
Start Date
August 4 2017
End Date
May 8 2020
Last Update
August 7 2020
Active Locations (2)
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1
Eskenazi Health System
Indianapolis, Indiana, United States, 46202
2
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202