DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017