Status:
COMPLETED
Fondaparinux in Critically Ill Patients With Renal Failure
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief 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...
Detailed Description
We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure (AKI) with intermittent hemod...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01467583
Start Date
November 1 2011
End Date
November 1 2013
Last Update
June 19 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Detroit Medical Center
Detroit, Michigan, United States, 48201