Clinical trial NCT00555438: Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Orthopaedic Surgery and Renal Impairment
Keywords: major orthopaedic surgery
venous thromboembolic events prevention
renal impairment
Arixtra
anti-Xa activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-11-08
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Number of Patients With Major Bleedings Between Day 1 and Day 10.
timeFrame: 10 day
Secondary outcomes:
measure: Number of Patients With Major Bleedings at 1 Month ± 5 Days.
timeFrame: 45 day
measure: Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10
timeFrame: 10 days
measure: Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days
timeFrame: at 1 month ± 5
measure: Death at 1 Month ± 5 Days
timeFrame: 1 month ± 5 days
Other outcomes:
Locations:
city: Agen
country: France
facility: GARANGER Thierry
city: Annonay
country: France
facility: CHARRET Françoise
city: Bayonne
country: France
facility: BONNEMAISON Julie
city: Bobigny
country: France
facility: BELLOUCIF Sadek
city: Bordeaux
country: France
facility: SZTARCK François
city: Caen
country: France
facility: PEGOIX Michel
city: Clamart
country: France
facility: AUSSET Sylvain
city: Clermont-ferrand
country: France
facility: SCHOEFFLER Pierre
city: Dijon
country: France
facility: LETOURNEAU Bernard
city: La Roche Sur Yon
country: France
facility: TISSIER Dominique
city: Le Mans
country: France
facility: LEMANISSIER Denis
city: Lyon
country: France
facility: CHAMBON Françoise
city: Lyon
country: France
facility: BEGOU Gérard
city: Montpellier
country: France
facility: CAPDEVILLA Xavier
city: Nantes
country: France
facility: PERON Alain
city: Nice
country: France
facility: GAERTNER Elisabeth
city: Nimes
country: France
facility: RIPART Jacques
city: Niort
country: France
facility: CHEVALEREAUD Erick
city: Paris
country: France
facility: LANGERON Olivier
city: Paris
country: France
facility: RABUEL Christophe
city: Paris
country: France
facility: MAZUIRE Elisabeth
city: Poitiers
country: France
facility: THERY Philippe
city: Reims
country: France
facility: BARRE Jeanne
city: Rouen
country: France
facility: LIGNOT Sophie
city: SAINt-ETIENNE
country: France
facility: MARTIN
city: Saint-etienne
country: France
facility: BAYLOT Denis
city: Saint-saulve
country: France
facility: DUVERGER Daniel
city: Toulouse
country: France
facility: FUZIER Régis
city: Tours
country: France
facility: COUVRET Claude
Study officials:
affiliation: CHU SAINT-ETIENNE
name: MISMETTI Patrick, MD
role: PRINCIPAL_INVESTIGATOR
References: