drugset / Trial / NCT01467583

Fondaparinux in Critically Ill Patients With Renal Failure

NCT01467583

Phase 4 Completed 32 enrolled Wayne State University GlaxoSmithKline · collab
Non-randomizedSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2011-11
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 2.5 mg Subcutaneous