Major Orthopaedic Surgery and Renal Impairment Clinical Trial
— PROPICEOfficial title:
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the
European Authorities in venous thromboembolic event prevention after major orthopaedic
surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF).
The bleeding risk associated with this prescription is highly related to renal function
evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been
proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn
instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on
simulated pharmakinetic data without any support of clinical data.
prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5
mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl
between 20 and 30 ml/min and undergoing a major orthopaedic surgery.
| Status | Completed |
| Enrollment | 451 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - • age > 18 years old, - undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or 2nd indication, - 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. Exclusion Criteria: - contra-indications to fondaparinux, - history of heparin inducted thrombopenia (HIT), - platelets < 100 g/l. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | GARANGER Thierry | Agen | |
| France | CHARRET Françoise | Annonay | |
| France | BONNEMAISON Julie | Bayonne | |
| France | BELLOUCIF Sadek | Bobigny | |
| France | SZTARCK François | Bordeaux | |
| France | PEGOIX Michel | Caen | |
| France | AUSSET Sylvain | Clamart | |
| France | SCHOEFFLER Pierre | Clermont-ferrand | |
| France | LETOURNEAU Bernard | Dijon | |
| France | TISSIER Dominique | La Roche Sur Yon | |
| France | LEMANISSIER Denis | Le Mans | |
| France | BEGOU Gérard | Lyon | |
| France | CHAMBON Françoise | Lyon | |
| France | CAPDEVILLA Xavier | Montpellier | |
| France | PERON Alain | Nantes | |
| France | GAERTNER Elisabeth | Nice | |
| France | RIPART Jacques | Nimes | |
| France | CHEVALEREAUD Erick | Niort | |
| France | LANGERON Olivier | Paris | |
| France | MAZUIRE Elisabeth | Paris | |
| France | RABUEL Christophe | Paris | |
| France | THERY Philippe | Poitiers | |
| France | BARRE Jeanne | Reims | |
| France | LIGNOT Sophie | Rouen | |
| France | BAYLOT Denis | Saint-etienne | |
| France | MARTIN | SAINt-ETIENNE | |
| France | DUVERGER Daniel | Saint-saulve | |
| France | FUZIER Régis | Toulouse | |
| France | COUVRET Claude | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne | GlaxoSmithKline |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Major Bleedings Between Day 1 and Day 10. | evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L. | 10 day | Yes |
| Secondary | Number of Patients With Major Bleedings at 1 Month ± 5 Days. | evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days. | 45 day | Yes |
| Secondary | Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10. | 10 days | No |
| Secondary | Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days. | at 1 month ± 5 | No |
| Secondary | Death at 1 Month ± 5 Days | Evaluate the total number of death at 1 month ± 5 days | 1 month ± 5 days | Yes |