Overview
Sponsor-declared trial summary
Coagulation in pediatric cardiac surgery
To investigate the differences in coagulation variables just after surgery between FFP and S/D plasma (Omniplasma) use. The main coagulation variables of interest are protein S activity and α2-ntiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, throm…
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2024-09-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514073-22-01
- EudraCT number
- 2021-000444-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To investigate the differences in coagulation variables just after surgery between FFP and S/D plasma (Omniplasma) use. The main coagulation variables of interest are protein S activity and α2-ntiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen.
Conditions and MedDRA coding
Coagulation in pediatric cardiac surgery
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514073-22-00 | Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Informed consent
- Cardiac surgery with the use of CPB
- Group 1A and Group 2A children < 1 year old
- Group 1B and Group 2B Glenn / Fontan surgery
Exclusion criteria 4
- No informed consent
- Cardiac surgery without the use of CPB
- Preoperative known coagulation disorders
- Known allergy for FFP or Omniplasma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB118891 · Substance
- Active substance
- Plasma
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3500
- Max total dose
- 3500
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Omniplasma 45-70 mg/ml oplossing voor infusie
PRD311829 · Product
- Active substance
- Human Plasma Protein
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 3500 ml millilitre(s)
- Max total dose
- 3500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05AA — BLOOD SUBSTITUTES AND PLASMA PROTEIN FRACTIONS
- Marketing authorisation
- RVG 25407
- MA holder
- OCTAPHARMA GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Research office Cardiothoracic Surgery
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Research office Cardiothoracic Surgery
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514073-22-01 | 4 |
| Recruitment arrangements (for publication) | Blank document for CTIS submission | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 202100044422 | 3.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FFP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Omniplasma | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514073-22-01 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2024-514073-22-01 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-04 | Netherlands | Acceptable with conditions 2024-09-23
|
2024-09-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-01 | Netherlands | Acceptable 2026-05-22
|
2026-05-22 |