Thrombolysis of symptomatic proximal vein thrombosis
Conditions
Brief summary
Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30, Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15
Detailed description
Ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7, Day 30 and Day 90, respectively., Change from baseline in leg pain severity at 6h, 24h, Day 7, Day 30 and Day 90 (Likert pain scale), Change from baseline in post- venous thromboembolism functional status (PVFS) scale at Day 7, Day 30 and Day 90, Number participants with recurrent venous thromboembolism (VTE) up to Day 90
Interventions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30, Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7, Day 30 and Day 90, respectively., Change from baseline in leg pain severity at 6h, 24h, Day 7, Day 30 and Day 90 (Likert pain scale), Change from baseline in post- venous thromboembolism functional status (PVFS) scale at Day 7, Day 30 and Day 90, Number participants with recurrent venous thromboembolism (VTE) up to Day 90 | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Slovakia, Spain
Outcome results
None listed