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Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.

NCT ID: NCT00555438

Last Updated: 2011-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Major Orthopaedic Surgery and Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery

Group Type EXPERIMENTAL

fondaparinux 1.5 mg/day

Intervention Type DRUG

Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery

Interventions

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fondaparinux 1.5 mg/day

Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Saint Etienne

Principal Investigators

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MISMETTI Patrick, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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GARANGER Thierry

Agen, , France

Site Status

CHARRET Françoise

Annonay, , France

Site Status

BONNEMAISON Julie

Bayonne, , France

Site Status

BELLOUCIF Sadek

Bobigny, , France

Site Status

SZTARCK François

Bordeaux, , France

Site Status

PEGOIX Michel

Caen, , France

Site Status

AUSSET Sylvain

Clamart, , France

Site Status

SCHOEFFLER Pierre

Clermont-Ferrand, , France

Site Status

LETOURNEAU Bernard

Dijon, , France

Site Status

TISSIER Dominique

La Roche-sur-Yon, , France

Site Status

LEMANISSIER Denis

Le Mans, , France

Site Status

CHAMBON Françoise

Lyon, , France

Site Status

BEGOU Gérard

Lyon, , France

Site Status

CAPDEVILLA Xavier

Montpellier, , France

Site Status

PERON Alain

Nantes, , France

Site Status

GAERTNER Elisabeth

Nice, , France

Site Status

CHEVALEREAUD Erick

Niort, , France

Site Status

RIPART Jacques

Nîmes, , France

Site Status

LANGERON Olivier

Paris, , France

Site Status

RABUEL Christophe

Paris, , France

Site Status

MAZUIRE Elisabeth

Paris, , France

Site Status

THERY Philippe

Poitiers, , France

Site Status

BARRE Jeanne

Reims, , France

Site Status

LIGNOT Sophie

Rouen, , France

Site Status

MARTIN

Saint-Etienne, , France

Site Status

BAYLOT Denis

Saint-Etienne, , France

Site Status

DUVERGER Daniel

Saint-Saulve, , France

Site Status

FUZIER Régis

Toulouse, , France

Site Status

COUVRET Claude

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2007-001048-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0701017

Identifier Type: -

Identifier Source: org_study_id

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