Fondaparinux in Critically Ill Patients With Renal Failure

Venous Thromboembolism Clinical Trial

Official title:

Use of Fondaparinux in Critically Ill Patients With Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467583
• Other study ID #: 112050
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2011
• Last updated: June 18, 2015
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: June 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 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 ml/min, will be safe and effective.

Description:

We will be studying fondaparinux 2.5 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old and = 89 years old

2. Body weight = 50 kg or = 150 kg

3. Estimated creatinine clearance of < 30 mL/min

4. Predicted ICU stay of more than 72 hours.

Exclusion Criteria:

1. Pregnant women

2. Infective Endocarditis

3. Neuraxial anesthesia or spinal puncture

4. Active bleeding

5. Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin

6. Signs of disseminated intravascular coagulation

7. Severe liver failure (serum bilirubin > 5 mg/dL)

8. Surgery planned within 24 hours of ICU admission

9. Latex allergy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Renal Insufficiency
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux
2.5 mg every 48 hours

Locations

Country	Name	City	State
United States	Detroit Medical Center	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.	Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.	2 years	No
Secondary	To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period	Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study	2 years	Yes