E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pulmonary insufficiency, which cannot be treated with measures of mechanical ventilation alone, Conditions in which veno-venous extracorporeal membrane oxygenation therapy is indicated |
|
E.1.1.1 | Medical condition in easily understood language |
patients with pulmonary diseases, in which normal mechanical ventilation is not sufficient to oxygenate the blood flowing through the lungs. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069144 |
E.1.2 | Term | Acute respiratory insufficiency |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038701 |
E.1.2 | Term | Respiratory insufficiency |
E.1.2 | System Organ Class | 100000004855 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Clotting events, platelet count, general heparin dose, coagulation specific biomarkers, inflammation specific biomarkers |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
over 18 years need of ECMO therapy for more than 24 hours |
|
E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
number of packed red blood cells per group |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of ECMO therapy |
|
E.5.2 | 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)
|
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E.5.2.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
independent monitoring of main endpoints is planned throughout the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |