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Fondaparinux in Critically Ill Patients With Renal Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467583
First Posted: November 8, 2011
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Steven Dov Tennenberg, MD, Wayne State University
  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
Intervention Model: Single Group Assignment
Masking: None (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 Steven Dov Tennenberg, MD, 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 ]
    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 ]
    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

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 3, 2011
First Posted: November 8, 2011
Results First Submitted: March 17, 2015
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Steven Dov Tennenberg, MD, Wayne State University:
Fondaparinux
Renal Failure
Critically Ill

Additional relevant MeSH terms:
Critical Illness
Thromboembolism
Renal Insufficiency
Venous Thromboembolism
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents