Fondaparinux in Critically Ill Patients With Renal Failure

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 89 years old

2. Body weight ≥ 50 kg or ≤ 150 kg

3. Estimated creatinine clearance of < 30 mL/min

4. Predicted ICU stay of more than 72 hours.

Exclusion Criteria:

1. Pregnant women

2. Infective Endocarditis

3. Neuraxial anesthesia or spinal puncture

4. Active bleeding

5. Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin

6. Signs of disseminated intravascular coagulation

7. Severe liver failure (serum bilirubin > 5 mg/dL)

8. Surgery planned within 24 hours of ICU admission

9. Latex allergy