Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heart Center Leipzig at University of Leipzig | UNKNOWN |
| Helios Health Institute GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional care | Active Comparator | Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines |
|
| Early Catheter-Interventional Treatment + conventional care | Experimental | Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Catheter-Interventional Treatment | Procedure | Patients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock |
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality at day 7 after randomization | 7 days |
| PE-related mortality | PE-related mortality at day 7 after randomization |
Not provided
Inclusion Criteria:
Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP <90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
Age ≥18 years
Exclusion Criteria:
Contraindications for catheter-based treatment
Contraindications to systemic fibrinolytic treatment or anticoagulation*
Pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl Fengler, MD, Assoc. Prof. | Contact | +49 341 865-1426 | karl.fengler@medizin.uni-leipzig.de | |
| Holger Thiele, MD, Prof. Dr. | Contact | holger.thiele@medizin.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Karl Fengler, MD, Assoc. Prof. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Study Chair |
| Holger Thiele, MD. Prof. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Recruiting | Bad Krozingen | 79189 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional care | Drug | reperfusion treatment |
|
| 7 days |
| Mortality (all-cause) | Mortality (all-cause) at day 30 after randomization | 30 days |
| Bail out therapy | Bail out therapy at day 7 after randomization | 7 days |
| GUSTO moderate or severe bleeding | GUSTO moderate or severe bleeding up to 7 days after randomization | 7 days |
| VA-ECMO use | VA-ECMO use between randomization and day 7 after randomization | 7 days |
| Change in echocardiographic parameters | Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization | 24 hours |
| Days of ICU stay | Days of ICU stay | 30 days |
| Time to hemodynamic stabilization | Time to hemodynamic stabilization | 30 days |
| Oberlausitzklinikum Bautzen, Medizinische Klinik I | Recruiting | Bautzen | 02625 | Germany |
|
| Universitätsklinikum Bonn | Recruiting | Bonn | 53127 | Germany |
|
| Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie | Recruiting | Düsseldorf | 40225 | Germany |
|
| HELIOS Klinikum Erfurt | Recruiting | Erfurt | 99089 | Germany |
|
| Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie | Recruiting | Frankfurt am Main | 60590 | Germany |
|
| Universitätsklinikum Halle | Recruiting | Halle | 06120 | Germany |
|
| Asklepios Klinik St. Georg | Recruiting | Hamburg | 20099 | Germany |
|
| SLK-Kliniken Heilbronn | Recruiting | Heilbronn | 74078 | Germany |
|
| Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2 | Recruiting | Kaiserslautern | 67655 | Germany |
|
| Universitätsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
|
| Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Recruiting | Leipzig | 04289 | Germany |
|
| Universitätsklinikum Mannheim | Recruiting | Mannheim | 68167 | Germany |
|
| Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd | Recruiting | Nuremberg | 90471 | Germany |
|
| Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie | Recruiting | Ulm | 89081 | Germany |
|
| Schwarzwald-Baar-Klinikum | Recruiting | Villingen-Schwenningen | 78052 | Germany |
|
| Rems-Murr-Kliniken | Recruiting | Winnenden | 71364 | Germany |
|
| Helios Kliniken Wuppertal | Recruiting | Wuppertal | 42117 | Germany |
|
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided