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

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

Drug Information available for: 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:	451
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 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
Study First Received:	November 7, 2007
Last Updated:	October 13, 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 January 15, 2009