Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Wayne State University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT00424281
First received: January 17, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention Phase
ICU Patients 18 Years or Older.
Drug: Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: January 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00424281

Contacts
Contact: Jorge A. Guzman, MD 313/745-8334 JGuzman@med.wayne.edu
Contact: Roze S. Kadri, MPA, MS 313/745-2361 RKadri@med.wayne.edu

Locations
United States, Michigan
Harper University Hospital, ICU Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Jorge A. Guzman, MD    313-745-8334    JGuzman@med.wayne.edu   
Principal Investigator: Jorge A. Guzman, MD         
Sponsors and Collaborators
Wayne State University
GlaxoSmithKline
Investigators
Study Chair: M. Safwan Badr, MD Wayne State University, Division of Pulmonary, Asthma, Critical Care, and Sleep Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00424281     History of Changes
Other Study ID Numbers: WSU protocol ID= 066706MP4F
Study First Received: January 17, 2007
Last Updated: January 17, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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 September 18, 2014