Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
NCT03404635
ABOUT THIS STUDY
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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.
- 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
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Descriptive Information | |||||
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Brief Title | Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism | ||||
Official Title | Monotherapy Anticoagulation To Expedite Home Treatment of Venous | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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 (-). | ||||
Condition | Venous Thromboembolism | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 1300 | ||||
Original Estimated Enrollment | 850 | ||||
Actual Study Completion Date | May 8, 2020 | ||||
Actual Primary Completion Date | May 8, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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 | ||||
Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03404635 | ||||
Other Study ID Numbers | CV185-562 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Jeffrey Kline, Indiana University | ||||
Study Sponsor | Indiana University | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | Indiana University | ||||
Verification Date | August 2020 |