Fondaparinux in Critically Ill Patients With Renal Failure

Completed · Phase 4

Conditions studied: Venous Thromboembolism

In brief

The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (VTE). Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of \< 30 ml/min, will be safe and effective.

Key facts

Study ID

NCT01467583

Run by

Wayne State University

People needed

32

Starts

2011-11-01

Expected to finish

2013-11-01

Last updated by the study team

2015-06-19

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old and ≤ 89 years old
• Body weight ≥ 50 kg or ≤ 150 kg
• Estimated creatinine clearance of < 30 mL/min
• Predicted ICU stay of more than 72 hours.

You may not qualify if…

• Pregnant women
• Infective Endocarditis
• Neuraxial anesthesia or spinal puncture
• Active bleeding
• Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin
• Signs of disseminated intravascular coagulation
• Severe liver failure (serum bilirubin > 5 mg/dL)
• Surgery planned within 24 hours of ICU admission
• Latex allergy

Where it is running

• Detroit Medical Center — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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