Clinical Trial Results:
A prospective randomized, double blind study on safety and efficacy of Alprostadil as additional Anticoagulant in Patients with veno- venous ECMO
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Summary
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EudraCT number |
2015-005014-30 |
Trial protocol |
AT |
Global end of trial date |
01 Nov 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Apr 2023
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First version publication date |
28 Apr 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AlproECMO_1.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02895373 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Internal Medicine I, Medical University of Vienna, +43 14040044920, thomas.staudinger@meduniwien.ac.at
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Scientific contact |
Internal Medicine I, Medical University of Vienna, +43 14040044920, thomas.staudinger@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2021
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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.
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Protection of trial subjects |
Predefined criteria for study discontinuation were used including bleeding type 3 or higher according to the BARC bleeding classification, a decrease in platelet count <50x109/l despite platelet transfusions, or the occurrence of heparin-induced thrombocytopenia according to the 4Ts score with the presence of platelet factor 4 antibodies.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
43
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients receiving ECMO were screened for eligibility. | |||||||||
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Pre-assignment
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Screening details |
not applicable | |||||||||
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Period 1
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Period 1 title |
Recruitment Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||
Blinding implementation details |
Patients were randomly assigned in a 1:1 ratio to receive PGE1 or placebo (0.9% saline). Randomization was performed by a pharmacist at the local pharmacy using consecutively numbered randomization envelopes with the information of the study group. Both study medications were prepared by pharmacists in ready-to-use motor pumps identical in appearance using a patient identifier. Upon arrival of the study medication, the study coordinator immediately administered the study medication
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention (PGE1) | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Prostaglandin E1
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
5 ng/kg/min continuously administered
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Arm title
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Placebo (0.9% NaCl) | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% NaCl
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
continuously administered
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 2 patients were enrolled but did not receive study medication as they fulfilled drop out criteria shortly after enrollment but before study drug administration |
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Baseline characteristics reporting groups
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Reporting group title |
Recruitment Period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention (PGE1)
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Reporting group description |
- | ||
Reporting group title |
Placebo (0.9% NaCl)
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Reporting group description |
- | ||
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End point title |
PRBC transfusion rate | |||||||||
End point description |
number of units of packed red blood cells transfused per 100 study days
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End point type |
Primary
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End point timeframe |
From start to end of study medication administration
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Statistical analysis title |
Between group comparison | |||||||||
Comparison groups |
Intervention (PGE1) v Placebo (0.9% NaCl)
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
6 months
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
24.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No serious adverse events in relation to study drug administration occured |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/35426776 |
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