Pulmonary Embolism Acute Massive
Conditions
Keywords
pulmonary embolism, early catheter-directed treatment
Brief summary
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
Interventions
PROCEDUREEarly Catheter-Interventional Treatment
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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
DRUGConventional care
reperfusion treatment
Sponsors
Leipzig Heart Science gGmbH
Heart Center Leipzig at University of Leipzig
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Age ≥18 years
Exclusion criteria
1. Contraindications for catheter-based treatment 2. Contraindications to systemic fibrinolytic treatment or anticoagulation\* 1. Active, potentially life-threatening bleeding 2. Surgery within 24h before screening 3. Cranial or spinal surgery within 14d before screening 4. Stroke within 14d before screening 5. Intracranial tumor 6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator 3. Pregnancy * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock | 7 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 7 days | All-cause mortality at day 7 after randomization |
| PE-related mortality | 7 days | PE-related mortality at day 7 after randomization |
| Mortality (all-cause) | 30 days | Mortality (all-cause) at day 30 after randomization |
| Bail out therapy | 7 days | Bail out therapy at day 7 after randomization |
| GUSTO moderate or severe bleeding | 7 days | GUSTO moderate or severe bleeding up to 7 days after randomization |
| VA-ECMO use | 7 days | VA-ECMO use between randomization and day 7 after randomization |
| Change in echocardiographic parameters | 24 hours | Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization |
| Days of ICU stay | 30 days | Days of ICU stay |
| Time to hemodynamic stabilization | 30 days | Time to hemodynamic stabilization |
Countries
Germany
Contacts
CONTACTKarl Fengler, MD, Assoc. Prof.
CONTACTHolger Thiele, MD, Prof. Dr.
STUDY_CHAIRKarl Fengler, MD, Assoc. Prof.
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
STUDY_CHAIRHolger Thiele, MD. Prof.
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Outcome results
None listed