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

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Patients With Major Bleedings Between Day 1 and Day 10. [ Time Frame: 10 day ] [ Designated as safety issue: Yes ]
evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.

Secondary Outcome Measures:

Number of Patients With Major Bleedings at 1 Month ± 5 Days. [ Time Frame: 45 day ] [ Designated as safety issue: Yes ]
evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.
Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.
Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days [ Time Frame: at 1 month ± 5 ] [ Designated as safety issue: No ]
Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.
Death at 1 Month ± 5 Days [ Time Frame: 1 month ± 5 days ] [ Designated as safety issue: Yes ]
Evaluate the total number of death at 1 month ± 5 days

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
Experimental: 1 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
GARANGER Thierry
Agen, France, 47000
CHARRET Françoise
Annonay, France, 07100
BONNEMAISON Julie
Bayonne, France, 64109
BELLOUCIF Sadek
Bobigny, France, 93009
SZTARCK François
Bordeaux, France, 33000
PEGOIX Michel
Caen, France, 14000
AUSSET Sylvain
Clamart, France, 92140
SCHOEFFLER Pierre
Clermont-ferrand, France, 63000
LETOURNEAU Bernard
Dijon, France, 21079
TISSIER Dominique
La Roche Sur Yon, France, 85016
LEMANISSIER Denis
Le Mans, France, 72000
CHAMBON Françoise
Lyon, France, 69006
BEGOU Gérard
Lyon, France, 69437
CAPDEVILLA Xavier
Montpellier, France, 34295
PERON Alain
Nantes, France, 44200
GAERTNER Elisabeth
Nice, France, 06200
RIPART Jacques
Nimes, France, 30029
CHEVALEREAUD Erick
Niort, France, 79006
RABUEL Christophe
Paris, France, 75014
MAZUIRE Elisabeth
Paris, France, 75679
LANGERON Olivier
Paris, France, 75013
THERY Philippe
Poitiers, France, 86035
BARRE Jeanne
Reims, France, 51092
LIGNOT Sophie
Rouen, France, 76031
BAYLOT Denis
Saint-etienne, France, 42013
MARTIN
SAINt-ETIENNE, France, 42 055
DUVERGER Daniel
Saint-saulve, France, 59880
FUZIER Régis
Toulouse, France, 31059
COUVRET Claude
Tours, France, 37044

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

GlaxoSmithKline

Investigators

Principal Investigator:

MISMETTI Patrick, MD

CHU SAINT-ETIENNE

More Information

No publications provided

Responsible Party:	Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00555438 History of Changes
Other Study ID Numbers:	0701017, 2007-001048-32
Study First Received:	November 7, 2007
Results First Received:	September 15, 2010
Last Updated:	July 22, 2011
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

Additional relevant MeSH terms:

Thromboembolism
Renal Insufficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Kidney Diseases
Urologic Diseases
Fondaparinux

PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012