Clinical Research Directory

Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria. A Randomised Trial

Main objective of this multisite randomised study aims to demonstrate in patients with active cancer and symptomatic or incidental PE without HESTIA criteria, that home treatment is non-inferior to hospitalisation as regards the 14-day rate of the composite primary endpoint. Primary endpoint corresponds to the rate of the composite of centrally adjudicated recurrent incidental or symptomatic VTE (i.e. non fatal or fatal PE, proximal and/or distal deep venous thrombosis (DVT) of lower limb or upper limb or catheter-related thrombosis), major or clinically relevant non-major bleeding and all-cause death within 14 days following randomisation. This composite endpoint represents the net clinical benefit of outpatient care. Included patients will be randomised into two groups and stratified according to symptomatic or incidental PE, site of cancer, localised or metastatic cancer and centre. Patients randomised to the home-treatment group will be discharged home within 24hrs after randomisation. Patients will be contacted by the local thrombosis team by phone within 7 days following inclusion. Patients randomised to the hospitalisation group will be admitted in the hospital during at least 48hrs after randomisation. After this time, physicians in charge of the patients will be free to discharge the patients.