Catheter-directed thrombolysis in patients with intermediate-high risk acute pulmonary embolism: a randomized pilot study

Fakultní nemocnice Královské Vinohrady0 个研究点目标入组 28 人开始时间: 2022年1月31日最近更新: 2022年6月20日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35620984/ (added 08/06/2022)

•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

•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

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