Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
Information source: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Orthopaedic Surgery and Renal Impairment
Intervention: fondaparinux 1.5 mg/day (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centre Hospitalier Universitaire de Saint Etienne Official(s) and/or principal investigator(s): MISMETTI Patrick, MD, Principal Investigator, Affiliation: CHU SAINT-ETIENNE
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Patients With Major Bleedings Between Day 1 and Day 10.
Secondary outcome: Number of Patients With Major Bleedings at 1 Month ± 5 Days.Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days Death at 1 Month ± 5 Days
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GARANGER Thierry, Agen 47000, France
CHARRET Françoise, Annonay 07100, France
BONNEMAISON Julie, Bayonne 64109, France
BELLOUCIF Sadek, Bobigny 93009, France
SZTARCK François, Bordeaux 33000, France
PEGOIX Michel, Caen 14000, France
AUSSET Sylvain, Clamart 92140, France
SCHOEFFLER Pierre, Clermont-ferrand 63000, France
LETOURNEAU Bernard, Dijon 21079, France
TISSIER Dominique, La Roche Sur Yon 85016, France
LEMANISSIER Denis, Le Mans 72000, France
BEGOU Gérard, Lyon 69437, France
CHAMBON Françoise, Lyon 69006, France
CAPDEVILLA Xavier, Montpellier 34295, France
PERON Alain, Nantes 44200, France
GAERTNER Elisabeth, Nice 06200, France
RIPART Jacques, Nimes 30029, France
CHEVALEREAUD Erick, Niort 79006, France
LANGERON Olivier, Paris 75013, France
MAZUIRE Elisabeth, Paris 75679, France
RABUEL Christophe, Paris 75014, France
THERY Philippe, Poitiers 86035, France
BARRE Jeanne, Reims 51092, France
LIGNOT Sophie, Rouen 76031, France
BAYLOT Denis, Saint-etienne 42013, France
MARTIN, SAINt-ETIENNE 42 055, France
DUVERGER Daniel, Saint-saulve 59880, France
FUZIER Régis, Toulouse 31059, France
COUVRET Claude, Tours 37044, France
Additional Information
Starting date: June 2007
Last updated: July 22, 2011
|