Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424281
Status:
UNKNOWN
Last Update Posted:
2007-01-19
First Post:
2007-01-17
Brief Title:
Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Pharmacokinetics of Fondaparinux Arixtra to Critically Ill Patients on Vasopressor Therapy
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie plasma concentration of subcutaneously administered fondaparinux ie 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 25 mg in young male subjects Cmax of 034 mg free acidL is reached in approximately 2 hours In patients undergoing treatment with fondaparinux sodium injection 25 mg once daily the peak steady-state plasma concentration is on average 039-050 mg free acidL and is reached approximately 3 hours post-dose Because fondaparinux does not react with platelet factor IV thrombocytopenia is not an unwanted side effect
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 ie plasma concentration of subcutaneously administered fondaparinux ie 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 25 mg in young male subjects Cmax of 034 mg free acidL is reached in approximately 2 hours In patients undergoing treatment with fondaparinux sodium injection 25 mg once daily the peak steady-state plasma concentration is on average 039-050 mg free acidL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None