Clinical Trial Results:
A prospective randomized pilot trial on safety and feasibility of Argatroban as anticoagulant in patients with extracorporeal membrane oxygenation (ECMO)
Summary
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EudraCT number |
2021-001456-34 |
Trial protocol |
AT |
Global end of trial date |
07 Jul 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Sep 2024
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First version publication date |
25 Sep 2024
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Other versions |
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 |
ArgatrobanECMO_1.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienna, Austria, 1090
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Public contact |
Department of Medicine I, ICU 13i2, Medical University of Vienna, +43 14040044570,
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Scientific contact |
Department of Medicine I, ICU 13i2, Medical University of Vienna, +43 14040044570,
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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 |
06 Aug 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Jul 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Jul 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• Safety of Argatroban as anticoagulant in ECMO
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Protection of trial subjects |
Subjects may prematurely discontinue from the study at any time. Premature discontinuation from the study means that the subject did not undergo an end of study examination as planned per protocol.
Subjects must be withdrawn under the following circumstances:
• at their own request
• if the Investigator feels it would not be in the best interest of the subject to continue (e.g. severe bleeding, severe thrombosis, ongoing difficulties to reach target values, need for major surgery)
• if the subject violates conditions laid out in the consent form / information sheet or disregards instructions by the study personal
• Switch to argatroban:
• confirmed HIT (following 4Ts score and PF4-antibody testing)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 May 2021
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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: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
27
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
40 | |||||||||
Number of subjects completed |
40 | |||||||||
Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Argatroban | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Argatroban
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Anticoagulant and preservative solution for blood
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Routes of administration |
Intravenous use
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Dosage and administration details |
Starting dose: 0.2µg/kg/min, titration according to target range
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Arm title
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Unfractionated Heparin | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Unfractionated Heparin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Anticoagulant and preservative solution for blood
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Routes of administration |
Intravenous use
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Dosage and administration details |
According to anticoagulation target
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Baseline Data
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End points reporting groups
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Reporting group title |
Argatroban
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Reporting group description |
- | ||
Reporting group title |
Unfractionated Heparin
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Reporting group description |
- | ||
Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Baseline Data
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End point title |
Safety and Efficacy | ||||||||||||
End point description |
Combined endpoint of clinically relevant bleeding or thromboembolism
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End point type |
Primary
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End point timeframe |
Inclusion until End of Study
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Statistical analysis title |
Pearson’s Chi-squared test | ||||||||||||
Comparison groups |
Argatroban v Unfractionated Heparin
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.7 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Inclusion until End of Study
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
unexpected adverse events
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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 unexpected serious or non-serious adverse events were observed during the study |
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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 |