Overview
Sponsor-declared trial summary
heart disease
Primary objective: The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free and total drug will be compared between the control and intervention group.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518338-10-00
- EudraCT number
- 2020-003174-50
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
Primary objective: The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free and total drug will be compared between the control and intervention group.
Conditions and MedDRA coding
heart disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- written informed consent
- Planned use of cardiopulmonary bypass
- Age: > 18 and < 90 years
- Ejection fraction > 40%
Exclusion criteria 12
- Inability to give informed consent
- Known allergy to penicillin/cephalosporins or cefazolin
- Preoperative antibiotic therapy
- Preoperative serum albumin concentration <40g/L
- Emergency procedure
- Preoperative renal failure
- Chronic severe renal insufficiency including hemodialysis
- Chronic severe liver disease
- BMI > 35
- Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus
- Pregnant women
- The standardized priming solution (1500ml Ringer’s Lactate, 100ml Mannit 20% and 10.000IE Heparin) is deemed inappropriate according to the treating physicians
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Kefzol 2 g – Trockensubstanz zur Infusionsbereitung
PRD4852200 · Product
- Active substance
- Cefazolin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 g gram(s)
- Max total dose
- 200 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DB04 — -
- Marketing authorisation
- 15.877
- MA holder
- ASTRO-PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Human Albumin „CSL Behring“ ® 20 % Infusionslösung
PRD11535689 · Product
- Active substance
- Human Plasma Proteins with Not Less Than 96% Albumin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 6 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05AA01 — ALBUMIN
- Marketing authorisation
- 235939
- MA holder
- CSL BEHRING GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-12-10 | 2024-12-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518338-10-00_redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_redacted | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Austria | Acceptable 2024-12-06
|
2024-12-10 |