Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01467583
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2011-11-03
Brief Title:
Fondaparinux in Critically Ill Patients With Renal Failure
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Use of Fondaparinux in Critically Ill Patients With Renal Failure
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
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:
The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 25 milligrams mg subcutaneously administered every q 48 hours hr in patients with renal failure achieves peak and trough levels similar to patients with normal renal function and protects patients from developing venous thromboembolism VTE Our hypothesis is that a dose-adjusted fondaparinux regimen which extends the dosing interval from q24 to q48 hr in patients with estimated creatinine clearance of 30 mlmin will be safe and effective
Detailed Description:
We will be studying fondaparinux 25 mg subcutaneously every 48 hr in three distinct patient groups 1 Acute kidney failure without hemodialysis 2 Acute kidney failure AKI with intermittent hemodialysis IHD and 3 Acute renal failure with continuous renal replacement therapy CRRT 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 DVT 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 2 grams gm 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 intensive care unit ICU stay through reevaluation of levels over time
Secondary objectives will be safety and accumulation Safety will be determined by assessment of clinically significant bleeding defined as a drop in Hgb of 2 grams gm 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 intensive care unit ICU stay through reevaluation of levels over time
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