Overview
Sponsor-declared trial summary
Lung transplantation
To investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 9 Dec 2022 → 14 Nov 2025
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519503-10-00
- EudraCT number
- 2022-001697-58
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response
Conditions and MedDRA coding
Lung transplantation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Adult recipients over the age of 18 at the time of the procedure, receiving a double lung transplantation (including lungs after ex-vivo lung perfusion) within the Vienna Lung Transplant Program
- Informed consent
Exclusion criteria 9
- Single lung transplantation
- Re-transplantation
- Previous major thoracic surgery (excluding pleural drainage, VATS biopsy)
- ECMO bridge to transplantation
- COVID-ARDS as transplant indication
- Pre-operative anti- coagulation/anti-platelet treatment
- Paediatric transplantation
- Multi- organ transplantation
- Active pregnancy or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- arterial or venous thromboembolic events
- circuit-related thrombosis
Secondary endpoints 2
- serious bleeding
- in-house mortality rate
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Heparin Gilvasan 5000 IE/ml – Injektions-/Infusionslösung
PRD305776 · Product
- Active substance
- Heparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10000 IU international unit(s)
- Max total dose
- 10000 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- 1-11741
- MA holder
- GILVASAN PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Isotone Natriumchloridlösung 0,9 % Braun Injektionslösung
PRD567881 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 6697366.00.00
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- 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
- Department of Thoracic Surgery
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Thoracic Surgery
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 80 | 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 | 2022-12-09 | 2023-06-29 | 2025-11-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519503-10-00_redacted | 5.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults_redacted | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Heparin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-17 | Austria | Acceptable 2025-01-30
|
2025-01-30 |