PGE1 as Additive Anticoagulant in ECMO-Therapy

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Staudinger
• Treatments: Alprostadil; Anticoagulants

Criteria

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