Phase 4
Completed N=32
Fondaparinux in Critically Ill Patients With Renal Failure
Source: ClinicalTrials.gov NCT01467583 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Jun 2015
Primary outcomePrimary: To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux. — 0.42; 0.31; 0.37; 0.18 mcg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux. |
0.42; 0.31; 0.37; 0.18; 0.12; 0.17 | — |
| SECONDARY To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old and ≤ 89 years old
- Body weight ≥ 50 kg or ≤ 150 kg
- Estimated creatinine clearance of 5 mg/dL)
- Surgery planned within 24 hours of ICU admission
- Latex allergy
Data sourced from ClinicalTrials.gov (NCT01467583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.