|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Centre Hospitalier Universitaire de Saint Etienne GlaxoSmithKline |
| Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00555438 |
Purpose
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.
| Condition | Intervention | Phase |
|
Major Orthopaedic Surgery and Renal Impairment |
Drug: fondaparinux 1,5 mg/day |
Phase IV |
| ChemIDplus related topics: | Fondaparinux sodium ORG 31540 |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
| Official 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 |
| Enrollment: | 450 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
patients with renal impairment who received Fondaparinux 1,5 mg/l after major orthopaedic surgery
|
Drug: fondaparinux 1,5 mg/day
Subcutaneous injection of fondaparinux 1,5 mg/l after major orthopaedic surgery
|
Fondaparinux 1,5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.
Screening visit : > 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• age > 18 years old,
Exclusion Criteria:
Contacts and Locations| France | |||||
| MAZUIRE Elisabeth | |||||
| PARIS, France, 75679 | |||||
| MARTIN | |||||
| SAINt-ETIENNE, France, 42 055 | |||||
| BARRE Jeanne | |||||
| REIMS, France, 51092 | |||||
| BAYLOT Denis | |||||
| SAINT-ETIENNE, France, 42013 | |||||
| BEGOU Gérard | |||||
| LYON, France, 69437 | |||||
| CAPDEVILLA Xavier | |||||
| MONTPELLIER, France, 34295 | |||||
| CHEVALEREAUD Erick | |||||
| NIORT, France, 79006 | |||||
| FUZIER Régis | |||||
| TOULOUSE, France, 31059 | |||||
| SZTARCK François | |||||
| BORDEAUX, France, 33000 | |||||
| LETOURNEAU Bernard | |||||
| DIJON, France, 21079 | |||||
| LANGERON Olivier | |||||
| PARIS, France, 75013 | |||||
| DUVERGER Daniel | |||||
| SAINT-SAULVE, France, 59880 | |||||
| PEGOIX Michel | |||||
| CAEN, France, 14000 | |||||
| COUVRET Claude | |||||
| TOURS, France, 37044 | |||||
| LEMANISSIER Denis | |||||
| LE MANS, France, 72000 | |||||
| CHARRET Françoise | |||||
| ANNONAY, France, 07100 | |||||
| TISSIER Dominique | |||||
| LA ROCHE SUR YON, France, 85016 | |||||
| SCHOEFFLER Pierre | |||||
| CLERMONT-FERRAND, France, 63000 | |||||
| GARANGER Thierry | |||||
| AGEN, France, 47000 | |||||
| LIGNOT Sophie | |||||
| ROUEN, France, 76031 | |||||
| RABUEL Christophe | |||||
| PARIS, France, 75014 | |||||
| BELLOUCIF Sadek | |||||
| BOBIGNY, France, 93009 | |||||
| BONNEMAISON Julie | |||||
| BAYONNE, France, 64109 | |||||
| RIPART Jacques | |||||
| NIMES, France, 30029 | |||||
| GAERTNER Elisabeth | |||||
| NICE, France, 06200 | |||||
| PERON Alain | |||||
| NANTES, France, 44200 | |||||
| CHAMBON Françoise | |||||
| LYON, France, 69006 | |||||
| AUSSET Sylvain | |||||
| CLAMART, France, 92140 | |||||
| THERY Philippe | |||||
| POITIERS, France, 86035 | |||||
| Centre Hospitalier Universitaire de Saint Etienne |
| GlaxoSmithKline |
| Principal Investigator: | MISMETTI Patrick, MD | CHU SAINT-ETIENNE |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne ( Pr Patrick MISMETTI ) |
| Study ID Numbers: | 0701017, EudraCT number 2007-001048-32 |
| First Received: | November 7, 2007 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00555438 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
|
|
|