Details

Autor(en) / Beteiligte

• Buchtele, Nina
• Schörgenhofer, Christian
• Schwameis, Michael
• Jilma, Bernd
• Schellongowski, Peter
• Herkner, Harald
• Riss, Katharina
• Schmid, Monika
• Hermann, Alexander
• Robak, Oliver
• Nagler, Bernhard
• Traby, Ludwig
• Bojic, Andja
• Staudinger, Thomas

Titel

Add-on Prostaglandin E1 in Venovenous Extracorporeal Membrane Oxygenation: A Randomized, Double-blind, Placebo-controlled Pilot Trial

Ist Teil von

• American journal of respiratory and critical care medicine, 2022-07, Vol.206 (2), p.170-177

Ort / Verlag

United States: American Thoracic Society

Erscheinungsjahr

2022

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Prostaglandin E1 (alprostadil; PGE1), in addition to low-dose unfractionated heparin, increases the biocompatibility of extracorporeal systems and enhances the efficacy of artificial organs without increasing bleeding risk. We investigated the safety and efficacy of PGE1 in adults receiving venovenous extracorporeal membrane oxygenation. This study was a randomized, double-blind, placebo-controlled phase-II-pilot trial at two medical intensive care units at the Medical University of Vienna, Austria. Adults with venovenous extracorporeal membrane oxygenation were randomly assigned to receive an intravenous infusion of 5 ng/kg/min PGE1 or placebo (0.9% saline), in addition to standard anticoagulation with unfractionated heparin. The primary outcome was the rate of transfused packed red blood cells per ECMO day. Secondary outcomes were the incidence of and the time to clinically overt bleeding and thromboembolic events. A post-hoc subgroup analysis included only patients with COVID-19. Between September 2016 and April 2021, of 133 screened patients, 50 patients were randomized, of whom 48 received the assigned study medication (24 per group). The transfusion rate was similar between groups (0.41vs.0.39;p=0.733). Prostaglandin E1 was associated with fewer thromboembolic events (7vs.16;p=0.020) and longer thromboembolism-free time (HR 0.302;p=0.01), fewer clinically overt bleeding events (2vs.11;p=0.017), and longer bleeding-free time (HR 0.213;p=0.047). In COVID-19 patients (n=25), the hazard ratios for clinically significant bleeding and thromboembolism were 0.276 (95% CI 0.035-2.186) and 0.521 (95% CI 0.149-1.825), respectively. Add-on treatment with PGE1 was safe but did not meet the primary endpoint of reducing the rate of red blood cell transfusions in patients on venovenous ECMO. Larger studies need to evaluate the safety and efficacy of additional PGE1 in ECMO. Clinical trial registration available at www. gov, ID: NCT02895373.