Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication

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. Identifier: NCT00424281
Recruitment Status : Unknown
Verified January 2007 by Wayne State University.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2007
Last Update Posted : January 19, 2007
Information provided by:
Wayne State University

Brief Summary:
Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.

Condition or disease Intervention/treatment
ICU Patients 18 Years or Older. Drug: Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability

Detailed Description:

In view of the high risk of venous thrombolism (VTE) in critically ill patients, it is essential for all ICUs to develop a standardized approach to thromboprophylaxis. Several studies in a critical setting have shown that both low dose unfractionated heparin and low molecular weight heparin (LMWH) reduce the incidence of VTE and either one of them is recommended as a valid agent by the newer ACCP consensus guidelines.

However, even with prophylaxis, critically ill patients still develop VTE. Common conditions amongst ICU patients such as generalized edema, poor peripheral perfusion during shock states, moderate renal dysfunction, etc., are possible explanations for this observation. Additionally, the use of vasoactive drugs may also impair peripheral circulation and reduce effective levels of agents used for the prevention of VTE.

This prospective clinical trial will be conducted to assess whether impaired peripheral circulation due to vasopressor (blood pressure) infusion decreases the bioavailability (i.e., plasma concentration) of subcutaneously administered fondaparinux (i.e., does vasopressor infusion lower blood plasma concentrations of fondaparinux), thereby reducing the prophylactic benefits of fondaparinux administration.

Fondaparinux (Arixtra®) was chosen as the anti-thrombotic agent to be used in this study because of its unique pharmacological properties and its safety and efficacy amongst different medical populations. Fondaparinux sodium administered by subcutaneous injection is rapidly and completely absorbed (absolute bioavailability is 100%). Following a single subcutaneous dose of fondaparinux sodium 2.5 mg in young male subjects, Cmax of 0.34 mg free acid/L is reached in approximately 2 hours. In patients undergoing treatment with fondaparinux sodium injection 2.5 mg, once daily, the peak steady-state plasma concentration is, on average, 0.39-0.50 mg free acid/L and is reached approximately 3 hours post-dose. Because fondaparinux does not react with platelet factor IV, thrombocytopenia is not an unwanted side effect.

Study Type : Observational
Enrollment : 40 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy
Study Start Date : February 2007
Study Completion Date : January 2010

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ICU patients 18 or over, weight 50 kg or more in the ICU will be enrollment eligible. Pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.

Exclusion Criteria:

  • Patients under 18, weight less than 50 kg, pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.

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 identifier (NCT number): NCT00424281

Contact: Jorge A. Guzman, MD 313/745-8334
Contact: Roze S. Kadri, MPA, MS 313/745-2361

United States, Michigan
Harper University Hospital, ICU Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Jorge A. Guzman, MD    313-745-8334   
Principal Investigator: Jorge A. Guzman, MD         
Sponsors and Collaborators
Wayne State University
Study Chair: M. Safwan Badr, MD Wayne State University, Division of Pulmonary, Asthma, Critical Care, and Sleep Medicine Identifier: NCT00424281     History of Changes
Other Study ID Numbers: WSU protocol ID= 066706MP4F
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: January 19, 2007
Last Verified: January 2007

Keywords provided by Wayne State University:
Arixtra, fondaparinux, vasopressor, venous thrombolism

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents