Clinical Trial Results:
SUbstition of PERioperative Albumin Deficiency Disorders
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Summary
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EudraCT number |
2016-001313-24 |
Trial protocol |
DE |
Global end of trial date |
21 Apr 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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Summary report(s) |
Clinical Study Report SUPERADD |
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 |
SUPERADD
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03167645 | ||
WHO universal trial number (UTN) |
U1111-1181-2625 | ||
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Sponsors
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Sponsor organisation name |
School of Medicine of the Technical University of Munich
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Sponsor organisation address |
Ismaningerstrasse 22, Munich, Germany, 81675
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Public contact |
Klinik für Anästhesiologie und Intensivmedizin, Technische Universität München, Fakultät für Medizin, 49 8941409635, s.schaller@tum.de
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Scientific contact |
Klinik für Anästhesiologie und Intensivmedizin, Technische Universität München, Fakultät für Medizin, 49 8941409635, s.schaller@tum.de
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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 |
25 Aug 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jun 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Apr 2021
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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 |
Reduction of postoperative complications of either high-risk surgical procedures or high-risk surgical patients through perioperative therapy of hypoalbuminemia (defined as <30g/l).
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP).
Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision.
The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
During the intervention period subjects were under supervision of an anesthesiologist either in the operation room or postoperative care unit (PACU).
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Background therapy |
Standard of care, i.e., treatment of hypalbuminaemia only if serum albumin < 20 g/L and clinically necessary Concomitant medication and supportive therapy were carried out according to standard clinical guidelines and at the judgement of the investigators | ||
Evidence for comparator |
Human-Albumin 20 % Behring, salzarm Infusionslösung, solution for injection, CSL-Behring | ||
Actual start date of recruitment |
20 Jun 2017
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research, Efficacy | ||
Long term follow-up duration |
6 Months | ||
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 |
Germany: 600
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Worldwide total number of subjects |
600
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EEA total number of subjects |
600
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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) |
204
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From 65 to 84 years |
372
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85 years and over |
24
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Recruitment
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Recruitment details |
The study was conducted in Germany single-centre between June 20, 2017 (first Patient recruited) and June 3, 2020 (last patient completed). After screening, checking for in- and exclusion criteria, and signing of the informed consent forms, the subjects will be randomized either in the intervention or observation group. | ||||||||||||||||||
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Pre-assignment
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Screening details |
After giving their consent, the patient was included in the clinical study. Only patients who meet all inclusion criteria and who do not have any exclusion criteria were included in the clinical study (screening). As soon as hypoalbuminemia was found in the laboratory, randomization takes place. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | ||||||||||||||||||
Roles blinded |
Subject, Data analyst, Assessor | ||||||||||||||||||
Blinding implementation details |
Patient and outcome-assessor were blinded.
The therapy takes place perioperatively and in the recovery room according to the mentioned guidelines without blinding. The doctors on the wards who diagnose and treat postoperative complications and the study doctors who record the postoperative complications until discharge are blinded.
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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 | ||||||||||||||||||
Arm description |
goal-directed albumin therapy, i.e., treatment of hypalbuminaemia < 30< g/L with Human-Albumin 20 % Behring, salzarm Infusionslösung, solution for injection, CSL-Behring | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Human-Albumin 20% Behring
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Investigational medicinal product code |
ATC B05AA01
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
goal-directed albumin therapy, i.e., treatment of hypalbuminaemia < 30< g/L with Human-Albumin 20 % Behring, salzarm Infusionslösung, solution for injection, CSL-Behring
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Arm title
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Control-Group | ||||||||||||||||||
Arm description |
standard of care, i.e., treatment of hypalbuminaemia only if serum albumin < 20 g/L and clinically necessary | ||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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| Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: Patient and outcome-assessor blinded. |
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
goal-directed albumin therapy, i.e., treatment of hypalbuminaemia < 30< g/L with Human-Albumin 20 % Behring, salzarm Infusionslösung, solution for injection, CSL-Behring | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control-Group
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Reporting group description |
standard of care, i.e., treatment of hypalbuminaemia only if serum albumin < 20 g/L and clinically necessary | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
goal-directed albumin therapy, i.e., treatment of hypalbuminaemia < 30< g/L with Human-Albumin 20 % Behring, salzarm Infusionslösung, solution for injection, CSL-Behring | ||
Reporting group title |
Control-Group
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Reporting group description |
standard of care, i.e., treatment of hypalbuminaemia only if serum albumin < 20 g/L and clinically necessary | ||
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End point title |
Any complication CDC ≥ II within 15d | |||||||||
End point description |
Any complication CDC ≥ Grade II within 15 days
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End point type |
Primary
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End point timeframe |
15 days
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Attachments |
Primary Endoint |
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Statistical analysis title |
Risk difference | |||||||||
Comparison groups |
Intervention v Control-Group
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Number of subjects included in analysis |
592
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.39 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
-2.5
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Confidence interval |
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95% | |||||||||
sides |
2-sided
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lower limit |
-8.1 | |||||||||
upper limit |
3.2 | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Safety assessment was done until hospital discharge.
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Adverse event reporting additional description |
Safety assessment was done in 600 patients randomized according to POMS and Clavien-Dindo as for the primary and secondary outcomes.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
POMS, Clavien-Dindo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
999
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Interventionsgroup: HA Humanalbumin 20% Albumin > 30 g/l | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Control-Group: Standard of Care | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Oct 2018 |
The following major changes were included in the Amendment No. 1:
1. number of patients after interim analysis
2. Secondary endpoints (Clavien Dindo recording over the entire hospital stay)
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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 | |||
