Overview
Sponsor-declared trial summary
Burn injury
The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of allogenic transfusion, and (2) to investigate the extend of fibrinolysis during burn excisional surgery.
Key facts
- Sponsor
- Maasstad Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 3 Nov 2021 → 26 Nov 2025
- Decision date (initial)
- 2024-04-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Werven B.V. · Dutch Burn Foundation
External identifiers
- EU CT number
- 2024-513573-49-00
- EudraCT number
- 2020-005405-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of allogenic transfusion, and (2) to investigate the extend of fibrinolysis during burn excisional surgery.
Conditions and MedDRA coding
Burn injury
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Patients scheduled for burn excisional surgery 2. An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) 2 % body surface area excision planned (100-200 cc / %TBSA, based on retrospective data from Burn Centre Rotterdam), (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing). - ≥18 year
Exclusion criteria 1
- Patients with a recorded coagulopathy in their history - Severe kidney failure (creatinine >500 umol/L) - Allergy for tranexamic acid - Acute venous-/arterial thrombosis (ongoing thrombosis). A history of thrombosis is NOT an exclusion criterion - Diffuse intravascular coagulation - Pregnancy - History of epilepsy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main study endpoints are the volume of blood loss and the extend of fibrinolysis.
Secondary endpoints 1
- Blood transfusion requirements: - Number of blood product transfused Hospital Mortality Length of stay Operation success: - Success of skin graft (percentage successful take) Cardiopulmonary complication (i.e. arterial embolism) Neurologic complications (i.e. stroke, conclusion) Strength of the blood cloth and fibrin-structures
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cyklokapron 100 mg/ml, oplossing voor injectie/infusie.
PRD411630 · Product
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 45 mg/kg milligram(s)/kilogram
- Max total dose
- 45 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- RVG 05573
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumchloride 0,9%, oplossing voor infusie
PRD564004 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6 mmol/kg millimole(s)/kilogram
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- RVG 51045
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Maasstad Ziekenhuis Stichting
- Sponsor organisation
- Maasstad Ziekenhuis Stichting
- Address
- Maasstadweg 21
- City
- Rotterdam
- Postcode
- 3079 DZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Maasstad Ziekenhuis Stichting
- Contact name
- dr. C.H. van der Vlies
Public contact point
- Organisation
- Maasstad Ziekenhuis Stichting
- Contact name
- dr. C.H. van der Vlies
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 95 | 3 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2021-11-03 | 2021-12-06 | 2025-08-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | Netherlands | Acceptable 2024-04-26
|
2024-04-26 |