Overview
Sponsor-declared trial summary
Slipped capital femoral epiphysis (SCFE)
To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a proximal femoral and/or pelvic osteotomy (PFPO). Primary research question: Is pre-operative TXA administration associated with reduced intraoperative blood loss, compared to placebo, in chi…
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] - Musculoskeletal Diseases [C05]
- Trial duration
- 17 Apr 2023 → ongoing
- Decision date (initial)
- 2024-11-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516324-34-01
- EudraCT number
- 2022-002384-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a proximal femoral and/or pelvic osteotomy (PFPO).
Primary research question:
Is pre-operative TXA administration associated with reduced intraoperative blood loss, compared to placebo, in children undergoing a proximal femoral and/or pelvic osteotomy for DDH or other indications?
Secondary objectives 4
- Does pre-operative tranexamic acid (TXA) administration lead to a reduced number of patients with severe intraoperative blood loss (>500 ml, >20 ml/kg (severe), or > 35 ml/kg (massive)), compared to placebo?
- Does pre-operative TXA administration lead to shorter procedure time and hospital stay, compared to placebo?
- Does pre-operative TXA administration lead to a lower decrease in post-operative Hb, compared to placebo?
- What patient (e.g. demographics) and treatment characteristics (e.g. type of osteotomy, location, procedure time), besides TXA, are associated with intraoperative blood loss?
Conditions and MedDRA coding
Slipped capital femoral epiphysis (SCFE)
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Data collection and analysis The period between the first inclusion and the end of the data analysis
|
Randomised Controlled | Double | [{"id":93314,"code":5,"name":"Carer"},{"id":93311,"code":2,"name":"Investigator"},{"id":93313,"code":4,"name":"Analyst"},{"id":93312,"code":3,"name":"Monitor"},{"id":93310,"code":1,"name":"Subject"}] |
Regulatory references
- Scientific advice from competent authorities
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516324-34-00 | Reduction of blood loss in pediatric osteotomies around the hip - A randomized placebo-controlled trial with tranexamic acid | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Proximal femoral and/or pelvic osteotomy/ies
- 1-18 years old
- Any indication for surgery
- Performed at our institution
Exclusion criteria 7
- Contraindications for TXA
- Active use of alternative (anti)fibrinolytics
- Diagnosed bleeding or coagulation disorder
- Medical history of thromboembolic complications
- Use of hormonal contraception
- Insufficient Dutch language skills of the patient and/or caretakers
- No informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Estimated intraoperative blood loss (ml/kg)
Secondary endpoints 10
- Baseline demographic data
- Indication for surgery
- Prior surgery at same site
- Treatment characteristics
- Operative time
- Eventual additional antifibrinolytic agents administered during surgery (including TXA)
- Blood transfusions
- Pre- and postoperative blood values, including Hb
- Complications
- Duration of hospital stay
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB11214MIG · Substance
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 25 mg/kg milligram(s)/kilogram
- Max total dose
- 25 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 40 Other
- Max total dose
- 40 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- J.J. Tolk
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- J.J. Tolk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 180 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-04-17 | 2023-04-17 |
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 NL81872 078 22 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 1-11 yo | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-15 yo | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 16-18 yo | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tranexamic Acid | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Netherlands | Acceptable 2024-11-21
|
2024-11-21 |