Fondaparinux in Critically Ill Patients With Renal Failure

NCT01467583 | Completed Phase 4 Results

• 1 other identifier: 112050
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Keywords

Fondaparinux; Renal Failure; Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

  2 years

Study Arms (3)

Renal failure on intermittent dialysis

EXPERIMENTAL

These are patients with renal failure, on intermittent hemodialysis (IHD), receiving fondaparinux 2.5 mg subcutaneously every 48 hours

Drug: Fondaparinux

Renal failure-renal replacement therapy

EXPERIMENTAL

These are patients with renal failure, either acute or chronic, on continuous renal replacement therapy (CRRT) receiving fondaparinux 2.5 mg subcutaneously every 48 hours

Drug: Fondaparinux

Renal failure, not on dialysis

EXPERIMENTAL

These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours

Drug: Fondaparinux

Interventions

Fondaparinux DRUG

2.5 mg every 48 hours

Also known as: Arixtra

Renal failure on intermittent dialysis; Renal failure, not on dialysis; Renal failure-renal replacement therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old and ≤ 89 years old
• Body weight ≥ 50 kg or ≤ 150 kg
• Estimated creatinine clearance of \< 30 mL/min
• Predicted ICU stay of more than 72 hours.

You may not qualify if:

• Pregnant women
• Infective Endocarditis
• Neuraxial anesthesia or spinal puncture
• Active bleeding
• Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin
• Signs of disseminated intravascular coagulation
• Severe liver failure (serum bilirubin \> 5 mg/dL)
• Surgery planned within 24 hours of ICU admission
• Latex allergy

Sponsors & Collaborators

• Wayne State University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Renal Insufficiency; Critical Illness

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Krista Wahby, Critical Care Pharmacist in the Medical ICU
• Organization: Harper University Hospital

kwahby@dmc.org

313-745-2711

Study Officials

• Steven D Tennenberg, MD

  WSU, DMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Intensive Care Unit

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 19, 2015
• Results First Posted: June 19, 2015

Record last verified: 2015-06

Locations

US (1)