ISRCTN22121045Completed未知
Catheter-directed thrombolysis in patients with intermediate-high risk acute pulmonary embolism: a randomized pilot study
Fakultní nemocnice Královské Vinohrady0 sites28 target enrollmentStarted: January 31, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 28
Study Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35620984/ (added 08/06/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Aged >18 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
- •* A perfusion defect in at least one main or one lobar pulmonary artery evident on CTA
- •** RV/LV ratio =0.9 on transthoracic echocardiography or CTA
- •*** hs-troponin I (TnI) >53 ng/l (men) or >34 ng/l (women); NT-proBNP level >600 pg/ml
Exclusion Criteria
- •1. Active clinically significant bleeding
- •2. Any hemorrhagic 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. RV/LV ratio <0.7 on transthoracic echocardiography or CTA
- •6. Active malignancy or other severe illness with expected survival <2 years
- •7. Haemoglobin level <80 g/l; international normalised ratio >2.0, platelet count =100 x 10e9; creatinine level >200 µmol/l
- •8. Pregnant or breastfeeding, fertility without previous exclusion of gravidity
- •9. Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia
- •10. Participation in another clinical trial
Investigators
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