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

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ClinicalTrials.gov Identifier: NCT00555438
Recruitment Status : Completed
First Posted : November 8, 2007
Results First Posted : November 17, 2010
Last Update Posted : August 17, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Major Orthopaedic Surgery and Renal Impairment Drug: fondaparinux 1.5 mg/day Phase 4

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Patients With Major Bleedings Between Day 1 and Day 10. [ Time Frame: 10 day ]
    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 :
  1. Number of Patients With Major Bleedings at 1 Month ± 5 Days. [ Time Frame: 45 day ]
    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.

  2. Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 [ Time Frame: 10 days ]
    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.

  3. Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days [ Time Frame: at 1 month ± 5 ]
    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.

  4. Death at 1 Month ± 5 Days [ Time Frame: 1 month ± 5 days ]
    Evaluate the total number of death at 1 month ± 5 days



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
LANGERON Olivier
Paris, France, 75013
RABUEL Christophe
Paris, France, 75014
MAZUIRE Elisabeth
Paris, France, 75679
THERY Philippe
Poitiers, France, 86035
BARRE Jeanne
Reims, France, 51092
LIGNOT Sophie
Rouen, France, 76031
MARTIN
SAINt-ETIENNE, France, 42 055
BAYLOT Denis
Saint-etienne, France, 42013
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

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 ( EudraCT Number )
First Posted: November 8, 2007    Key Record Dates
Results First Posted: November 17, 2010
Last Update Posted: August 17, 2011
Last Verified: July 2011

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:
Renal Insufficiency
Thromboembolism
Kidney Diseases
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents