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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
reperfusion treatment
Universitätsklinikum Freiburg
Bad Krozingen, Germany
RECRUITINGUniversitätsklinikum Bonn
Bonn, Germany
RECRUITINGComposite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
1. mortality (all-cause) up to 7 days after randomization and 2. either one of the following 1. recurrent cardiac arrest or 2. persistent / recurrent shock (systolic BP \<90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization
Time frame: 7 days
All-cause mortality
All-cause mortality at day 7 after randomization
Time frame: 7 days
PE-related mortality
PE-related mortality at day 7 after randomization
Time frame: 7 days
Mortality (all-cause)
Mortality (all-cause) at day 30 after randomization
Time frame: 30 days
Bail out therapy
Bail out therapy at day 7 after randomization
Time frame: 7 days
GUSTO moderate or severe bleeding
GUSTO moderate or severe bleeding up to 7 days after randomization
Time frame: 7 days
VA-ECMO use
VA-ECMO use between randomization and day 7 after randomization
Time frame: 7 days
Change in echocardiographic parameters
Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Halle
Halle, Germany
RECRUITINGAsklepios Klinik St. Georg
Hamburg, Germany
RECRUITINGSLK-Kliniken Heilbronn
Heilbronn, Germany
RECRUITINGUniversitätsklinikum Leipzig
Leipzig, Germany
RECRUITINGHeart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, Germany
RECRUITINGUniversitätsklinikum Mannheim
Mannheim, Germany
RECRUITINGSchwarzwald-Baar-Klinikum
Villingen-Schwenningen, Germany
RECRUITINGRems-Murr-Kliniken
Winnenden, Germany
RECRUITING...and 1 more locations
Time frame: 24 hours
Days of ICU stay
Days of ICU stay
Time frame: 30 days
Time to hemodynamic stabilization
Time to hemodynamic stabilization
Time frame: 30 days