Pulmonary embolism
Conditions
Brief summary
Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and USAT combined) to heparin/LMWH group (n=140 versus n=70), Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70)
Detailed description
Bleeding complications (major and minor bleeding complication according the TIMI classification), Duration of index admission, including hospital-based rehabilitation, Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months, Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.), Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference., Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography, Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups, Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and USAT combined) to heparin/LMWH group (n=140 versus n=70), Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding complications (major and minor bleeding complication according the TIMI classification), Duration of index admission, including hospital-based rehabilitation, Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months, Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.), Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference., Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography, Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups, Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups | — |
Countries
Denmark