Clinical trial NCT01467583: Fondaparinux in Critically Ill Patients With Renal Failure
Official title: Use of Fondaparinux in Critically Ill Patients With Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Keywords: Fondaparinux
Renal Failure
Critically Ill
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

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 hemodialysis (IHD) and 3) Acute renal failure with continuous renal replacement therapy (CRRT). All patients will be assessed for efficacy of the dose. Efficacy will be assessed by following clinically for any evidence of VTE, either deep venous thrombosis (DVT) or pulmonary embolism. In addition, lower extremity duplex studies will be performed at baseline and at the end of the study period to assess for DVT.

Secondary objectives will be safety and accumulation. Safety will be determined by assessment of clinically significant bleeding, defined as a drop in Hgb of \> 2 grams (gm) in 24 hr, or the need for red blood cell transfusion related to bleeding. Accumulation may occur in renal failure and will be studied throughout the intensive care unit (ICU) stay through reevaluation of levels over time.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
Study officials:
affiliation: WSU, DMC
name: Steven D Tennenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: