Prospective, Multicentre, Open-Label Study Evaluating 1,5 mg/Day of Fondaparinux. - Full Text View

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

U.S. FDA Resources

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

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

evaluate between Day 1 and Day 10, the incidence of major bleedings. [ Time Frame: 45 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

evaluate the incidence of major bleedings at 1 month ± 5 days, of symptomatic DVT and PE between Day 1 and Day 10 and at 1 month ± 5 days and Pharmacokinetic parameters [ Time Frame: 45 day ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555438

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

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

GlaxoSmithKline

Investigators


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

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

major orthopaedic surgery

venous thromboembolic events prevention

renal impairment

Arixtra

anti-Xa activity

Study placed in the following topic categories:

Heparin, Low-Molecular-Weight

Fondaparinux

Org 31540

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Centre Hospitalier Universitaire de Saint Etienne GlaxoSmithKline
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00555438