Clinical trial • Phase IV • Musculoskeletal

TRANEXAMIC ACID for Slipped capital femoral epiphysis (SCFE) | Legg-Calvé-Perthes Disease (LCPD) | Neuromuscular conditions | Secondary hip dysplasia | Developmental dysplasia of the hip (DDH)

Phase IV trial of TRANEXAMIC ACID for Slipped capital femoral epiphysis (SCFE) | Legg-Calvé-Perthes Disease (LCPD) | Neuromuscular conditions | Secondary…

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Slipped capital femoral epiphysis (SCFE) | Legg-Calvé-Perthes Disease (LCPD) | Neuromuscular conditions | Secondary hip dysplasia | Developmental dysplasia of the hip (DDH)
Trial Stage
Phase IV
Drug Modality
Small molecule|Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
21-11-2024

Trial design

Randomised, test: tranexamic acid — active substance tranexamic acid, dose information: max total/daily amount listed as 25 mg/kg (doseuom mg/kg), route: intravenous bolus use. comparator/placebo: saline — route: intravenous injection (placebo).-controlled Phase IV trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Test: TRANEXAMIC ACID — active substance TRANEXAMIC ACID, dose information: max total/daily amount listed as 25 mg/kg (doseUom mg/kg), route: INTRAVENOUS BOLUS USE. Comparator/placebo: SALINE — route: INTRAVENOUS INJECTION (placebo).
Target Sample Size
180

Eligibility

Recruits 180 paediatric patients.

Vulnerable Population
Children (paediatric population aged 1-18 years) are selected as vulnerable population; subject information and informed consent forms are available for age groups: L1_SIS and ICF 1-11 yo, L1_SIS and ICF 12-15 yo, L1_SIS and ICF 16-18 yo, and Adults. Insufficient Dutch language skills of the patient and/or caretakers is listed as an exclusion, indicating consent/communication in Dutch is required.

Inclusion criteria

  • {"criterion_text":"- Proximal femoral and/or pelvic osteotomy/ies"}
  • {"criterion_text":"- 1-18 years old"}
  • {"criterion_text":"- Any indication for surgery"}
  • {"criterion_text":"- Performed at our institution"}

Exclusion criteria

  • {"criterion_text":"- Contraindications for TXA"}
  • {"criterion_text":"- Active use of alternative (anti)fibrinolytics"}
  • {"criterion_text":"- Diagnosed bleeding or coagulation disorder"}
  • {"criterion_text":"- Medical history of thromboembolic complications"}
  • {"criterion_text":"- Use of hormonal contraception"}
  • {"criterion_text":"- Insufficient Dutch language skills of the patient and/or caretakers"}
  • {"criterion_text":"- No informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Estimated intraoperative blood loss (ml/kg)","definition_or_measurement_approach":"Estimated intraoperative blood loss expressed in ml per kg (ml/kg)"}

Secondary endpoints

  • {"endpoint_text":"- Baseline demographic data","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Indication for surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Prior surgery at same site","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Treatment characteristics","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Operative time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Eventual additional antifibrinolytic agents administered during surgery (including TXA)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Blood transfusions","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Pre- and postoperative blood values, including Hb","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Complications","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of hospital stay","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
180
Recruitment Window Months
36
Consent Approach
Subject information and informed consent forms are provided for age-specific groups: 1-11 years, 12-15 years, 16-18 years, and Adults (documents listed: L1_SIS and ICF 1-11 yo; L1_SIS and ICF 12-15 yo; L1_SIS and ICF 16-18 yo; L1_SIS and ICF Adults). Insufficient Dutch language skills of the patient and/or caretakers is an exclusion criterion, indicating consent materials/communication are in Dutch.

Geography

Total Number Of Sites
1
Total Number Of Participants
180

Netherlands

Earliest CTIS Part Ii Submission Date
14-11-2024
Latest Decision Or Authorization Date
21-11-2024
Processing Time Days
7
Number Of Sites
1
Number Of Participants
180

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of Orthopaedics and Sports Medicine
Principal Investigator Name
J.J. Tolk
Principal Investigator Email
kinderorthopedie@erasmusmc.nl
Contact Person Name
J.J. Tolk
Contact Person Email
kinderorthopedie@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
TRANEXAMIC ACID
Active Substance
TRANEXAMIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS USE
Starting Dose
25 mg/kg
Dose Levels
25 mg/kg
Maximum Dose
25 mg/kg
Investigational Product Name
SALINE
Active Substance
SALINE
Modality
Other
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Maximum Dose
40 (unit: Other)

Related trials

Other published trials that may interest you.