NCT02895373

PGE1 as Additive Anticoagulant in ECMO-Therapy

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Thomas Staudinger · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prostaglandins may inhibit platelet activation via the P2Y1 ADP receptor. Platelets may contribute to thromboembolic complications and coagulation activation during ECMO therapy. Retrospective data suggest that treatment with PGE1 may serve beneficial by reducing the amount of heparin needed for inhibition of coagulation activation, and by reducing the thromboembolic risk without increasing the risk of bleeding. Inhibition of platelets via PGE1 (Alprostadil) may be interesting in this setting, because, in contrast to other platelet inhibitors, it has a very short half-life and platelets remain susceptible for activation by more potent agonists (i.e. thrombin, ADP). Thus, although reducing the contribution of platelets to coagulation activation, it may not affect safety of participating subjects. This randomized, double-blind, placebo controlled trial will investigate whether treatment of patients with ECMO therapy proves beneficial.

Conditions

• Respiratory Distress Syndrome, Adult
• Extracorporeal Membrane Oxygenation

Interventions

Type	Name	Description
DRUG	Alprostadil	5ng/kg/min, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy
DRUG	0.9% sodium chloride solution	continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-05-01
• Completion: 2021-07-01
• First posted: 2016-09-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Austria