1. A randomized trial of low-dose thrombolysis, ultrasound-assisted thrombolysis, or heparin for intermediate-high risk pulmonary embolism—the STRATIFY trial: design and statistical analysis plan
- Author
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Jesper Kjærgaard, Jørn Carlsen, Emilie Sonne-Holm, Sebastian Wiberg, Lene Holmvang, Jens Flensted Lassen, Rikke Sørensen, Dan Høfsten, Peter Sommer Ulriksen, Samir Jawad, Pernille Palm, Jens Jakob Thune, Christian Hassager, Ole P. Kristiansen, Kristian Eskesen, Søren Fanø, and Lia E. Bang more...
- Subjects
Pulmonary embolism ,Intermediate-high risk ,Low-dose thrombolysis ,Ultrasound-assisted thrombolysis ,Clot burden ,Medicine (General) ,R5-920 - Abstract
Abstract Background Intermediate-high risk pulmonary embolism (PE) carries a significant risk of hemodynamic deterioration or death. Treatment should balance efficacy in reducing clot burden with the risk of complications, particularly bleeding. Previous studies on high-dose, short-term thrombolysis with alteplase (rtPA) showed a reduced risk of hemodynamic deterioration but no change in mortality and increased bleeding complications. Catheter-based techniques, including ultrasound-assisted thrombolysis (USAT), and low-dose thrombolysis may offer reasonable efficacy with lower risk. However, studies comparing these methods have been few. This trial aims to address this gap by randomizing patients to three treatment modalities. Methods Multicenter, randomized trial with 1:1:1 allocation of 210 patients with acute intermediate-high risk PE, excluding those with absolute contraindications to thrombolysis. Patients are eligible for inclusion if they are > 18 years of age, have had symptoms more...
- Published
- 2024
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