Reduction of blood loss in pediatric surgical procedures around the hip- A trial with tranexamic acid –
- Conditions
- Osteotomies around the hip, i.e. proximal femoral and/or pelvic osteotomies (PFPO) in children, for e.g:- hip dysplasia- secondary hip dysplasia- hip incongruenties due to other problems (e.g. post trauma, slipped epiphysis, or infection)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2022-002384-30-NL
- Lead Sponsor
- Erasmus MC - Sophia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 180
The patient population is composed of all patients aged 1-18 years, undergoing a pelvic and/or femoral osteotomy (PFPO) at Erasmus MC-Sophia, for DDH, secondary hip dysplasia, or other indications.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Any indication for PFPO
•Age 1-18 years
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Contra-indication for TXA (active thromboembolic disease, subarachnoidal bleeding, severe renal insufficiency, history of convulsions, disseminated intravascular coagulation)
•Active use of alternative (anti)fibrinolytics
•Diagnosed bleeding or coagulation disorder
•Medical history of thromboembolic complications
•Insufficient Dutch Language skills of parents/care-takers
•No informed consent
•Use of hormonal contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method