Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban: Prospective Management Trial (HoT-PE) - HoT-PE

niversity Medical Center of the Johannes Gutenberg University Mainz0 sites576 target enrollmentJanuary 23, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Medical Center of the Johannes Gutenberg University Mainz
Enrollment: 576
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

January 23, 2017

End Date

November 26, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center of the Johannes Gutenberg University Mainz

•1\) Age \=18 years;
•2\) Ability of subject to understand character and individual consequences of clinical trial;
•3\) Signed and dated informed consent of the subject available before the start of any specific trial procedures;
•4\) Women of childbearing potential have to practice a medically accepted contraception (non\-hormonal intrauterine device, two independent barriers, female or male surgical sterilization, or two years postmeno\-pausal) during the trial, and a negative pregnancy test (serum or urine) should be available before inclusion in the trial;
•5\) Objectively confirmed diagnosis of acute PE by multidetector computed tomographic (CT) pulmonary angiography, pulmonary angiography, or V/Q lung scan according to established diagnostic criteria, with or without symptomatic deep vein thrombosis;
•6\) Absence of right ventricular (RV) enlargement or dysfunction, and of free floating thrombi
•in the right atrium or right ventricle on echocardiography or computed tomography.
•On echocardiography, RV enlargement/dysfunction is absent when both criteria listed
•below are met:
•\- Right/left ventricular end\-diastolic diameter ratio \< 0\.9 (apical or subcostal 4\-chamber

•\-Hemodynamic instability at presentation, indicated by at least one of the following: (i) systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>100 beats per minute, or SBP drop by \> 40 mm Hg, for \> 15 min; (ii) need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \>100 mm Hg; (iii) need for cardiopulmonary resuscitation;
•\-Right ventricular (RV) enlargement or dysfunction, or free floating thrombi in the right atrium or right ventricle, detected by echocardiography or computed tomography;
•\-Treatment with low\-molecular\-weight heparin, fondaparinux, or unfractionated heparin for more than 48 hours, or more than a single dose of a vitamin K antagonist prior to inclusion in the study;
•\-Treatment with rivaroxaban, dabigatran, apixaban, edoxaban or any other new generation antithrombotics on admission;
•\-Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
•\- Need for supplemental oxygen administration to maintain oxygen saturation \>90%;
•\-Pain requiring parenteral administration of analgesic agents;
•\-Other medical conditions/comorbidities requiring hospitalization;
•\- Acute PE diagnosed in a patient already hospitalized for another condition;
•\- Pregnancy or lactation;