Fondaparinux in Critically Ill Patients With Renal Failure

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Steven Dov Tennenberg, MD, Wayne State University
ClinicalTrials.gov Identifier:
NCT01467583
First received: November 3, 2011
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Fondaparinux
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Use of Fondaparinux in Critically Ill Patients With Renal Failure

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.


Secondary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study


Enrollment: 32
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal failure on intermittent dialysis
These are patients with renal failure, on intermittent hemodialysis (IHD), receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Drug: Fondaparinux
2.5 mg every 48 hours
Other Name: Arixtra
Experimental: Renal failure-renal replacement therapy
These are patients with renal failure, either acute or chronic, on continuous renal replacement therapy (CRRT) receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Drug: Fondaparinux
2.5 mg every 48 hours
Other Name: Arixtra
Experimental: Renal failure, not on dialysis
These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Drug: Fondaparinux
2.5 mg every 48 hours
Other Name: Arixtra

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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467583

Locations
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
GlaxoSmithKline
Investigators
Principal Investigator: Steven D Tennenberg, MD WSU, DMC
  More Information

No publications provided

Responsible Party: Steven Dov Tennenberg, MD, Director, Surgical Intensive Care Unit, Wayne State University
ClinicalTrials.gov Identifier: NCT01467583     History of Changes
Other Study ID Numbers: 112050
Study First Received: November 3, 2011
Results First Received: March 17, 2015
Last Updated: June 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Wayne State University:
Fondaparinux
Renal Failure
Critically Ill

Additional relevant MeSH terms:
Critical Illness
Renal Insufficiency
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Disease Attributes
Embolism and Thrombosis
Kidney Diseases
Pathologic Processes
Thrombosis
Urologic Diseases
Vascular Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015