Patients with renal impairment defined by a creatinin clearance between 20 and 50 ml/min and undergoing a major orthopaedic surgery (hip fracture, total hip replacement and total knee replacement) MedDRA version: 9.1 Level: LLT Classification code 10038474 Term: Renal insufficiency MedDRA version: 9.1 Level: LLT Classification code 10020100 Term: Hip fracture MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis MedDRA version: 9.1 Level: LLT Classification co
Conditions
Interventions
Trade Name: Arixtra 1,5 mg/0,3 ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fondaparinux
CAS Number: 114870-03-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
CHU SAINT-ETIENNE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient affiliated with or a beneficiary of a social security category: • age > 18 years old, • requiring a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or resumption, • requiring an antithrombotic prophylaxis, • presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault’s formula, • having signed the inform consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • contra-indications to fondaparinux, • history of heparin inducted thrombopenia (HIT), • history of venous thromboembolic event, • Haemorrhagic diathesis, • PT 1,5 of control value, platelets < 100 G/l. incapacity to understand protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate between D5 and D10, the incidence of major bleedings after a daily subcutaneous injection of fondaparinux 1,5 mg during at least 5 days for prevention of venous thromboembolic events after major orthopaedic surgery (TKR, THR and HF) in patients with a CrCl between 20 and 50 ml/min (estimated by Cockcroft and Gault formula). ;Secondary Objective: to evaluate: • The incidence of major bleedings at 1 month ± 5 days • The incidence of clinically significative bleedings between D5 and D10 and at 1 month ± 5 days • The incidence of symptomatic venous thromboembolic events (DVT and PE) between D5 and D10 and at 1 month ± 5 days • Pharmacodynamic parameters based on Xa activity (absorption half-life and elimination clearance of distribution volume and their variability) of fondaparinux based on a non-linear model at mixed effect and to compare the observed real clinical data with those simulated and described in MA file. • Estimation of haemorrhagic and thromboembolic risk factors. • Estimation of inter-laboratories variability in the measure of anti-Xa activity with fondaparinux;Primary end point(s): • Major bleeding (occuring between D5 and D10) is defined by: - an exteriorised bleeding with a bleeding index > 2 (g/dl of haemoglobin decrease + number of units transfused) - a bleeding needing a resumption surgery - a bleeding affecting a critical organ (ocular, retroperitoneal, pericardial, intra-cranial, intra-medullary, intramuscular with compression) - a fatal bleeding | — |
Countries
France
Outcome results
None listed