Clinical trial NCT00927602: Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
Official title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Medical Patients
Renal Insufficiency
Keywords: renal failure
medical patient
venous thromboembolism
prophylaxis
fondaparinux
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 206
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 60 years
* Acute medical disease requiring thromboprophylaxis according to international guidelines
* Anticipated immobilization of at least 4 days
* Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
* Written informed consent

Exclusion Criteria:

* Active bleeding or bleeding in the previous 3 months
* Known bleeding diathesis
* Platelet count \< 100.000
* Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
* Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
* Life expectancy \< 1 month

Primary outcomes:
measure: major bleeding
timeFrame: up to 48 hours from last injection
Secondary outcomes:
measure: symptomatic venous thromboembolism
timeFrame: last treatment dose
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University Of Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Walter Ageno, MD
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Francesco Dentali, MD
role: STUDY_DIRECTOR
affiliation: Università degli Studi dell'Insubria
name: Alessandro Squizzato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
citation: Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84. doi: 10.7326/0003-4819-144-9-200605020-00011.
citation: Ageno W, Riva N, Noris P, Di Nisio M, La Regina M, Arioli D, Ria L, Monzani V, Cuppini S, Lupia E, Giorgi Pierfranceschi M, Dentali F; FONDAIR study group. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study. J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.