Catheter-directed thrombolysis in patients with acute pulmonary embolism

Not Applicable

Completed

• Conditions: Acute pulmonary embolism; Circulatory System; Pulmonary embolism

• Registration Number: ISRCTN22121045
• Lead Sponsor: Fakultní nemocnice Královské Vinohrady

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-31
• Study Start: 2022-01-31
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified