CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Fondaparinuxdrug
Likely dose
Fondaparinux 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01467583
NCT01467583Phase 4Completed
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Use of Fondaparinux in Critically Ill Patients With Renal Failure

Wayne State University·interventional·Posted Nov 8, 2011·Updated Jun 19, 2015

In Brief

A Phase 4 clinical trial evaluating Fondaparinux for Venous Thromboembolism. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartNov 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.7 years ago

Interventions

Fondaparinuxdrug

2.5 mg every 48 hours