NCT02895373: ECMO_PGE1

A Prospective Randomized, Double Blind Study on Safety and Efficacy of Alprostadil as Additional Anticoagulant in Patients With Veno- Venous Extracorporeal Membrane Oxygenation (ECMO)

Terminated Phase 2 Last updated 25 January 2022

What this trial tests

Phase 2 trial testing Alprostadil in Respiratory Distress Syndrome, Adult in 50 participants. Terminated before completion.

Timeline

1 July 2016

Primary endpoint
1 May 2021

1 July 2021

Quick facts

Lead sponsor	Thomas Staudinger
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	1 July 2016
Primary completion	1 May 2021
Estimated completion	1 July 2021
Sites	1 location across Austria

Drugs / interventions tested

• Alprostadil (ALPROSTADIL) — full drug profile →
• 0.9% sodium chloride solution

Conditions studied

• Respiratory Distress Syndrome, Adult — all drugs for Respiratory Distress Syndrome, Adult →
• Extracorporeal Membrane Oxygenation — all drugs for Extracorporeal Membrane Oxygenation →

Sponsor

Thomas Staudinger

Who can join

18 and older, any sex, with Respiratory Distress Syndrome, Adult or Extracorporeal Membrane Oxygenation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Bleeding rate (quantified by the number of packed red blood cells transfused in relation to the duration of ECMO therapy)
  Time frame: up to 6 months
  The bleeding rate will be quantified by the number of packed red blood cells in relation to the duration of ECMO therapy. This duration may vary and cannot be predicted. Thus, we will calculate the required number of packed red blood cells i.e. per week.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
   Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
2. Challenges in ARDS Definition, Management, and Identification of Effective Personalized Therapies.
   Battaglini D, Fazzini B, Silva PL, Cruz FF, et al · · 2023 · cited 48× · PMID 36835919 · DOI 10.3390/jcm12041381
3. Add-On Prostaglandin E₁ in Venovenous Extracorporeal Membrane Oxygenation: A Randomized, Double-Blind, Placebo-controlled Pilot Trial.
   Buchtele N, Schörgenhofer C, Schwameis M, Jilma B, et al · · 2022 · cited 13× · PMID 35426776 · DOI 10.1164/rccm.202110-2359oc