Incidental Subsegmental Pulmonary Embolism in cancer patients
Conditions
Brief summary
WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis
Detailed description
Clinically relevant bleeding (major bleeding + CRNMB based on the ISTH- definition), Venous thromboembolism other than pulmonary embolism verified by imaging, Progression, stability or resolution of thrombosis on imaging, assessed by two independent radiologists, Discontinuation of cancer treatment related to pulmonary embolism or pulmonary embolism treatment, Quality of life assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L), pulmonary embolism quality of life questionnaire (PEmb-QoL) and the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30)
Interventions
DRUGEDOXABAN
DRUGDALTEPARIN
DRUGTINZAPARIN
DRUGAPIXABAN
DRUGENOXAPARIN
DRUGRIVAROXABAN
Sponsors
Region Hovedstaden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically relevant bleeding (major bleeding + CRNMB based on the ISTH- definition), Venous thromboembolism other than pulmonary embolism verified by imaging, Progression, stability or resolution of thrombosis on imaging, assessed by two independent radiologists, Discontinuation of cancer treatment related to pulmonary embolism or pulmonary embolism treatment, Quality of life assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L), pulmonary embolism quality of life questionnaire (PEmb-QoL) and the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30) | — |
Outcome results
None listed