E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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) |
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E.1.1.1 | Medical condition in easily understood language |
Hip (development) problems in children, such as: - hip dysplasia - secondary hip dysplasia - hip incongruenties due to other problems (e.g. post trauma, slipped epiphysis, or infection) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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?
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E.2.2 | Secondary objectives of the trial |
Secondary research questions: - 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? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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: • Any indication for PFPO • Age 1-18 years |
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E.4 | Principal exclusion criteria |
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
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E.5 End points |
E.5.1 | Primary end point(s) |
- Estimated intraoperative blood loss (EBL in ml/kg, calculated with the level of suction fluids and number of soaked surgical swabs and drapes) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the surgical procedure (i.e. at day 1 of the study) |
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E.5.2 | Secondary end point(s) |
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 (first day after surgery), Hct and MCV, complications, duration of hospital stay. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of hospital stay (i.e. 1 day - several days)
There is no follow-up after surgery ans hospital stay for this study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Discharge from the hospital of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |