TerminatedPhase 2

PGE1 as Additive Anticoagulant in ECMO-Therapy

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

Austria50 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * minimum age 18 years * Veno-Venous- ECMO * Minimum of 24h planned ECMO- therapy Exclusion Criteria: * • Long- term therapy with other antiplatelet drugs including Acetyl Salicylic Acid * known Heparin induced thrombocytopenia * Bleeding diathesis = contraindication for heparin (e.g. GI-bleeding, Intracerebral bleeding) * Platelets \< 50 G/L * Thromboplastin time \< 50% * Pregnancy * Patient \< 18 years * prothrombin time \<50% Drop out criteria: * Major bleeding (from Type 3 bleeding; see "primary objective") * Occurrence of HIT (4 T- Score: Number of platelets, development over time, manifestation of thrombosis, other reasons for thrombocytopenia \[10\]) * Plt \< 50 G/l

What they're measuring

Bleeding rate (quantified by the number of packed red blood cells transfused in relation to the duration of ECMO therapy)

Timeframe: up to 6 months

Trial details

NCT IDNCT02895373

SponsorThomas Staudinger

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Adult trials