Apixaban
DrugApixaban as standard of care for VTE
NCT Number: NCT03404635
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Eskenazi Health System, Indianapolis, Indiana, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Apixaban as standard of care for VTE
Rivaroxaban as standard of care for VTE
Time frame: 30 days
Re-hospitalization for > 24 hours due to VTE recurrence or bleeding
Indiana University
Other
Monotherapy Anticoagulation To Expedite Home Treatment of Venous
Acronym: MATHVTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04992195
Alzheimer Disease, Arterial Thromboembolism
Hong Kong
View Trial DetailsNCT04736420
Cardiovascular Diseases, Embolism and Thrombosis
Boston, Massachusetts, United States
View Trial DetailsNCT06495996
Cardiovascular Diseases, Deep Venous Thrombosis
Newport Beach, California, United States
View Trial DetailsNCT07689136
Cardiovascular Diseases, Deep Vein Thrombosis
Tunis, Tunisia
View Trial Details