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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Pfizer | INDUSTRY |
| Janssen Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban for VTE |
| ||
| Rivaroxaban for VTE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Apixaban as standard of care for VTE |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of re-hospitalization visits for VTE recurrence or bleeding | Re-hospitalization for > 24 hours due to VTE recurrence or bleeding | 30 days |
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Inclusion Criteria:
Patients must be low risk, as defined by either A or B below:
A. The modified Hestia criteria:
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:
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 Criteria:
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
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Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health System | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34148351 | Derived | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Rivaroxaban |
| Drug |
Rivaroxaban as standard of care for VTE |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |