TINZAPARIN SODIUM for Pulmonary embolism

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Intermediate high-risk pulmenary embolism according to ESC criteria"}
• {"criterion_text":"- Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography"}
• {"criterion_text":"- 14 days of symptoms or less, with significant worsening of symptoms within 7 days"}
• {"criterion_text":"- Class II risk assessed by the Pulmonary Embolism Severity Index"}

Exclusion criteria

• {"criterion_text":"- Altered mental state (GCS < 14)"}
• {"criterion_text":"- No qualifying CT angiography performed (> 24 hour since CT angiography)"}
• {"criterion_text":"- Women of childbearing potential, unless negative HCG test is present"}
• {"criterion_text":"- Thrombolysis for PE within 14 days of randomization"}
• {"criterion_text":"- Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)"}
• {"criterion_text":"- Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)"}
• {"criterion_text":"- Comorbidity making 6 months survival unlikely"}
• {"criterion_text":"- Absolute contraindications for thrombolysis a.\tHistory of haemorrhagic stroke or stroke of unknown origin b.\tIschaemic stroke in previous 6 months c.\tCentral nervous system neoplasm d.\tMajor trauma, surgery, or head injury in previous 3 weeks a.\tBleeding diathesis – Active bleeding"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change (reduction) in modified Miller score assessing thrombus involvement and segmental flow on imaging; comparison between groups as specified (percutaneous treated combined vs heparin/LMWH)."}
• {"endpoint_text":"- Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70)","definition_or_measurement_approach":"Change (reduction) in modified Miller score assessing thrombus involvement and segmental flow on imaging; comparison between percutaneous embolectomy and USAT arms."}

Secondary endpoints

• {"endpoint_text":"- Bleeding complications (major and minor bleeding complication according the TIMI classification)","definition_or_measurement_approach":"Bleeding events classified according to the TIMI classification (major and minor)."}
• {"endpoint_text":"- Duration of index admission, including hospital-based rehabilitation","definition_or_measurement_approach":"Length of stay during index admission including any hospital-based rehabilitation (duration in days)."}
• {"endpoint_text":"- Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months","definition_or_measurement_approach":"Dyspnoea assessed using a visual analogue scale at 48-96 hours and at 3 months post-intervention."}
• {"endpoint_text":"- Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.)","definition_or_measurement_approach":"Incidence of additional interventions during admission for pulmonary embolism; recorded as occurrence of listed procedures/interventions."}
• {"endpoint_text":"- Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference.","definition_or_measurement_approach":"All-cause mortality comparison across arms using log-rank test and multivariable Cox regression to estimate hazard ratios (UFH/LMWH as reference)."}
• {"endpoint_text":"- Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography","definition_or_measurement_approach":"Echocardiographic assessment at 3 months to determine TR gradient; incidence of TR gradient > 40 mmHg recorded."}
• {"endpoint_text":"- Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups","definition_or_measurement_approach":"Six-minute walk test performed at 3 months; distance walked (meters) compared across groups."}
• {"endpoint_text":"- Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups","definition_or_measurement_approach":"Quality of life measured using the PEmbQoL instrument at 3 months; scores compared across groups."}

Denmark

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

539

Number Of Sites

4

Number Of Participants

210

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}