PGE1 as Additive Anticoagulant in ECMO-Therapy

Phase 2 Terminated 50 enrolled Thomas Staudinger

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

Timeline

Start: 2016-07
Primary completion: 2021-05
Completion: 2021-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “After completion of pilot study (n=50) no effect on primary outcome and limited feasibility of recruitment and study procedures”

paper Conclusions: Add-on treatment with PGE1 was safe but did not meet the primary endpoint of reducing the rate of red blood cell transfusions PMID 35426776 ↗

Publications

Buchtele N, Schorgenhofer C, Schwameis M, Jilma B, Schellongowski P, Herkner H, Riss K, Schmid M, Hermann A, Robak O, Nagler B, Traby L, Bojic A, Staudinger T. Add-On Prostaglandin E1 in Venovenous Extracorporeal Membrane Oxygenation: A Randomized, Double-Blind, Placebo-controlled Pilot Trial. Am J Respir Crit Care Med. 2022 Jul 15;206(2):170-177. doi: 10.1164/rccm.202110-2359OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alprostadil	Unknown	5 ng	Intravenous