Fondaparinux in Critically Ill Patients With Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Wayne State University.
Recruitment status was  Recruiting
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: July 16, 2012
Last verified: July 2012
  Purpose

The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 mg subcutaneously administered q 48 hr in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing VTE. Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 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:
  • Efficacy of the adjusted dose in achieving peak and trough levels similar to patients without renal failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Levels will be assessed throughout the study


Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety will be assessed through monitoring for bleeding as well as doppler monitoring at the beginning and end of the study.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal failure, on IHD
These are patients with renal failure, on intermittent dialysis
Drug: Fondaparinux
2.5 mg every 48 hours
Other Name: Arixtra
Experimental: Renal failure, on CRRT 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
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 with intermittent hemodialysis and 3) Acute renal failure with continuous renal replacement therapy. 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 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 > 2gm 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467583

Contacts
Contact: Krista A Wahby, Pharm.D. 313-745-2711 khby@dmc.org
Contact: Seven D Tenenberg stennenb@dmc.org

Locations
United States, Michigan
Detroit Medical Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Krista A Wahby, Pharm.D.    313-745-2711      
Principal Investigator: Krista A Wahby, Pharrm.D.         
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
Last Updated: July 16, 2012
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
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014