Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism
Background: Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite standard anticoagulation therapy. Previous efforts to decrease mortality in these patients via administration of systemic thrombolysis have failed due to an increased rate of major bleeding complicatio
| Condition(s) | Pulmonary Embolism |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Background: Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite standard anticoagulation therapy. Previous efforts to decrease mortality in these patients via administration of systemic thrombolysis have failed due to an increased rate of major bleeding complications. Catheter-directed thrombolysis (CDT) has already shown some promising results in terms of efficacy and safety, including the results of our randomized pilot study. However, large randomized trials with clinical endpoints comparing catheter-directed local thrombolysis versus standard anticoagulation therapy are still lacking, thus the treatment of intermediate-high risk acute PE patients has not changed for decades. Hypothesis: Catheter-directed local thrombolysis is super |
| Who can participate | Inclusion Criteria: 1. Age \> 18 years and not over 80 years. 2. Computed tomography angiography (CTA)-verified proximal\* PE AND symptom onset \< 14 days prior. 3. Intermediate-high risk PE with a SPESI score ≥ 1 AND RV dysfunction\*\* AND an elevated biomarker \*\*\* (hs-troponin or NT-proBNP) level. 4. Signed informed consent. Exclusion Criteria: 1. Active clinically significant bleeding. 2. Any haemorrhagic stroke OR a recent (\< 6 months) ischaemic stroke/transient ischaemic attack. 3. Recent (\< 3 months) cranial trauma OR another active intracranial/intraspinal process. 4. Major surgery within 7 days prior. 5. Active malignancy OR other severe illness with expected survival \< 2 years. 6. Haemoglobin level \< 80 g/L; international normalised ratio \> 2.0, platelet count ≤ 100 x 109; |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Faculty Hospital Kralovske Vinohrady |
| Locations | Prague, Czechia |
| Start date | 2022-10-19 |
| NCT ID | NCT05493163 |
| Official listing | https://clinicaltrials.gov/study/NCT05493163 |