Tenecteplase Pulmonary Embolism Italian Study
Pulmonary Embolism
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring pulmonary embolism, right ventricular dysfunction, thrombolysis, echocardiography
Eligibility Criteria
Inclusion Criteria: age between 18 and 85; symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography; normal blood pressure (SBP >100mmHg); RVD at echocardiography (see criteria); written informed consent. Exclusion Criteria: absence of RVD at echocardiography; shock or hypotension (SBP < 100 mmHg); therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization; administration of thrombolytic agents within the previous 4 days; vena cava filter insertion or pulmonary thrombectomy within the previous 4 days chronic pulmonary hypertension or severe COPD; hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation; use of GP IIb/IIIa antagonists within the preceding 7 days; significant bleeding disorders either at present or within the past 6 months; active peptic ulceration; known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions; known haemorrhagic diathesis; known arterial aneurysm and known arterial/venous malformation; known neoplasm with increased bleeding risk; prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks; current oral anticoagulation; major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months; any known history of stroke or transient ischaemic attack (TIA) or dementia; any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism; any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); known subacute bacterial endocarditis; known acute pancreatitis; known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; pregnancy or lactation or parturition within the previous 30 days; women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control; treatment with an investigational drug under another study protocol in the past 7 days; previous enrolment in this study; known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients; anticipated or obvious problem with vascular access; any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated; inability to follow protocol requirements
Sites / Locations
- Dipartimento di Cardiologia - Ospedale del Delta
- Unità Operativa di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Vimercate
- Divisione di Cardiologia - Azienda Ospedaliera - Ospedale Civile di Legnano
- Unità Operativa di Cardiologia - Ospedale di Circolo e Fondazione Macchi
- Divisione Medica II - Ospedale di Vimercate
- Medicina D'Urgenza e Pronto Soccorso - Opsedale Regionale
- Divisione di Cardiologia - Azienda Ospedaliera di Venere -Giovanni XXIII
- U.O. di Cardiologia - Ospedale di Bentivoglio
- Medicina d'Urgenza - Policlinico S. Orsola
- UTIC - Ospedale Civile di Brescia
- Reparto di Cardiologia - Casa di Cura Poliambulanza - Congregazione Suore Ancelle della Carità
- Medicina D'Urgenza, Cardiologia - Ospedale Civile "San Sebastiano"
- Dipartimento di Emergenza Accettazione - Azienda Ospedaliera Universitaria Careggi
- Divisione Medica II - Ospedale Galliera
- Dipartimento di Emegernza e Accetazione (DEA) - Az. Ospedale-Università San Martino di Genova
- Reparto di Cardiologia - Presidio Ospedaliero Piana di Lucca
- Dipartimento Cuore Polmone - Ospedale Carlo Poma
- Reparto di Cardiologia - Azienda Ospedaliera Fatebenfratelli Oftalmico
- Medicina D'Urgenza - Ospedale Maggiore Policlinico
- Reparto di Pneumologia - Ospedale San Giuseppe
- Unità Operativa di Cardiologia - Ospedale S Carlo Borromeo
- Medicina D'Urgenza - Az. Osped. Ospedale Niguarda "Cà Granda"
- Medicina Interna II - Azienda Ospedaliera "Maggiore della Carità" di Novara
- Department of Internal Medicine - University of Perugia
- Malattie Apparato Respiratorio - Ospedale Cisanello
- Reparto di Angiologia - Arcispedale Santa Maria Nuova
- Divisione di Cardiologia - Ospedale Civile
- Divisione di Pneumologia - Ospedale S Maria
- Medicina D'Urgenza - Azienda Ospedaliera S. Giovanni Battista "Le Molinette"
- Medicina D'Urgenza - Ospedale Cattinara