hip dislocation hip dysplasia
Conditions
Interventions
Randomisation for:
- Group A) single pre-operative intravenous bolus of TXA 15 mg/kg.
- Group B) single pre-operative intravenous bolus of placebo (no TXA).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: 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: • Indication for PFPO • Age 1-18 years
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: estimated intraoperative blood loss (EBL in ml/kg, calculated with the level of suction fluids and number of soaked surgical swabs and drapes). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: baseline demographic data, indication for surgery, prior surgery at same site, treatment (type of PFPO, pelvic and/or femur, side, uni/bilateral), operative time, eventual additional antifibrinolytic agents (including TXA) administered during surgery, blood transfusions, pre- and post-operative blood values including Hb, Hct and MCV, complications, duration of hospital stay. | — |
Countries
Netherlands
Outcome results
None listed