A prospective, randomized, double-blind trial on safety and efficacy of Alprostadil infusion as an additional Anticoagulant (to standard therapy heparin) in patients in need of extracorporeal lung assist therapy (veno-venous extracorporal membrane oxygenation)

A prospective randomized, double blind study on safety and efficacy of Alprostadil as additional Anticoagulant in Patients with veno- venous ECMO - AlproEcmo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005014-30-AT

Enrollment

Registered

2016-04-27

Start date

2016-06-02

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary insufficiency, which cannot be treated with measures of mechanical ventilation alone, Conditions in which veno-venous extracorporeal membrane oxygenation therapy is indicated MedDRA version: 19.0 Level: LLT Classification code 10069144 Term: Acute respiratory insufficiency System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10038701 Term: Respiratory insufficiency System Organ Class: 100000004855

Interventions

Trade Name: Alprostapint Product Name: Alprostadil Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Alprostadil CAS Number: 745-65-3 Current Sponsor code: Al

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: over 18 years need of ECMO therapy for more than 24 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Long- term therapy with other antiplatelet drugs (T-ASS max. 100 mg/d) • known HIT • bleeding tendency= Contraindication for Heparin (eg. GI-bleeding, Intracerebral bleeding) • Plt < 50 G/L • NT < 30% • Pregnancy • Patient < 18

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure efficacy of Alprostadil as an additional anticoagulant in patients treated with veno-venous ECMO therapy. Main objective is the reduction in bleeding rate assessed by need of packed red blood cells. ;Secondary Objective: Clotting events, platelet count, general heparin dose, coagulation specific biomarkers, inflammation specific biomarkers;Primary end point(s): number of packed red blood cells per group;Timepoint(s) of evaluation of this end point: at the end of ECMO therapy	—

Measure

Time frame

Main Objective: To measure efficacy of Alprostadil as an additional anticoagulant in patients treated with veno-venous ECMO therapy. Main objective is the reduction in bleeding rate assessed by need of packed red blood cells. ;Secondary Objective: Clotting events, platelet count, general heparin dose, coagulation specific biomarkers, inflammation specific biomarkers;Primary end point(s): number of packed red blood cells per group;Timepoint(s) of evaluation of this end point: at the end of ECMO therapy

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Secondary

Measure	Time frame
Secondary end point(s): - clotting events assessed by sonography at the canula locations, D-Dimer, optical (oxygenator), clinically obvious thrombosis - heparin dose - coagulation specific biomarkers (thrombelastometry, platelet function: platelet function analyzer 100, whole blood aggregometry, von Willebrand Syndrome diagnosis, - function of the oxygenator (Oxygen transfer, paO2 of the post-oxygenator blood), transmembrane pressure during therapy and before the end of ECMO therapy - Inflammatory parameters (CRP, etc.) - Hemodynamics (catecholamine use, blood pressure, cardiac output) ;Timepoint(s) of evaluation of this end point: - before start of ECMO therapy - 6-8 hours after start - 24 hours after start - 48 hours after start - 72 hours after start - twice weekly thereafter	—

Measure

Time frame

Secondary end point(s): - clotting events assessed by sonography at the canula locations, D-Dimer, optical (oxygenator), clinically obvious thrombosis - heparin dose - coagulation specific biomarkers (thrombelastometry, platelet function: platelet function analyzer 100, whole blood aggregometry, von Willebrand Syndrome diagnosis, - function of the oxygenator (Oxygen transfer, paO2 of the post-oxygenator blood), transmembrane pressure during therapy and before the end of ECMO therapy - Inflammatory parameters (CRP, etc.) - Hemodynamics (catecholamine use, blood pressure, cardiac output) ;Timepoint(s) of evaluation of this end point: - before start of ECMO therapy - 6-8 hours after start - 24 hours after start - 48 hours after start - 72 hours after start - twice weekly thereafter

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Countries

Austria

Contacts

Public ContactInternal Medicine I

Medical University of Vienna

thomas.staudinger@meduniwien.ac.at+4314040044920

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026