Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|ICU Patients 18 Years or Older.||Drug: Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability||Phase 4|
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|
|Estimated Enrollment :||40 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy|
|Study Start Date :||February 2007|
|Estimated Study Completion Date :||January 2010|
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): NCT00424281
|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|
|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|
|Study Chair:||M. Safwan Badr, MD||Wayne State University, Division of Pulmonary, Asthma, Critical Care, and Sleep Medicine|