An observational study in Venous Thromboembolism, sponsored by Indiana University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Indiana University · Observational
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.
Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).
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.
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
Drug: Apixaban
Drug: Rivaroxaban
Apixaban as standard of care for VTE
Rivaroxaban as standard of care for VTE
Number of re-hospitalization visits for VTE recurrence or bleeding
Re-hospitalization for \> 24 hours due to VTE recurrence or bleeding
Time frame: 30 days
Plan to share: Undecided
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Indiana University