Clinical trial • Phase IV • Cardiology

HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN for Heart disease|Hypoalbuminemia

Phase IV trial of HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN for Heart disease|Hypoalbuminemia.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart disease|Hypoalbuminemia
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
10-12-2024

Trial design

Randomised, open-label, control and intervention groups (control vs intervention). products listed in trial: kefzol (cefazolin) and human albumin 20%. specific arm dosing and schedule not specified in the available ctis data/documents. Phase IV trial across 1 site in Austria.

Randomised
Yes
Open Label
Yes
Comparator
Control and intervention groups (control vs intervention). Products listed in trial: Kefzol (cefazolin) and Human Albumin 20%. Specific arm dosing and schedule not specified in the available CTIS data/documents.
Target Sample Size
20

Eligibility

Recruits 20 Vulnerable population not selected; exclusion criterion: 'Inability to give informed consent'. Informed consent required (principal inclusion: 'written informed consent'). No assent or parental consent procedures described; no minors included..

Pregnancy Exclusion
Pregnant women
Vulnerable Population
Vulnerable population not selected; exclusion criterion: 'Inability to give informed consent'. Informed consent required (principal inclusion: 'written informed consent'). No assent or parental consent procedures described; no minors included.

Inclusion criteria

  • {"criterion_text":"-written informed consent\n-Planned use of cardiopulmonary bypass\n-Age: > 18 and < 90 years\n-Ejection fraction > 40%"}

Exclusion criteria

  • {"criterion_text":"-Inability to give informed consent\n-Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus\n-Pregnant women\n-The standardized priming solution (1500ml Ringer’s Lactate, 100ml Mannit 20% and 10.000IE Heparin) is deemed inappropriate according to the treating physicians\n-Known allergy to penicillin/cephalosporins or cefazolin\n-Preoperative antibiotic therapy\n-Preoperative serum albumin concentration <40g/L\n-Emergency procedure\n-Preoperative renal failure\n-Chronic severe renal insufficiency including hemodialysis\n-Chronic severe liver disease\n-BMI > 35"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.","definition_or_measurement_approach":"Compare AUC0-10 for free and total drug between the control and intervention groups (area under the concentration-time curve from 0-10 hours)."}

Recruitment

Planned Sample Size
20
Recruitment Window Months
14
Consent Approach
Written informed consent required from participants (principal inclusion criterion: 'written informed consent'). No assent or parental consent described. No information on age-specific documents or available languages provided.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Austria

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
40
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Contact Person Name
Doris Hutschala-Kinstner

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Human Albumin „CSL Behring“ ® 20 % Infusionslösung
Active Substance
HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation number 235939 (product entry present)
Maximum Dose
6 g
Investigational Product Name
Kefzol 2 g – Trockensubstanz zur Infusionsbereitung
Active Substance
CEFAZOLIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation number 15.877 (product entry present)
Maximum Dose
200 g

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