Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.

Study Overview

• Status: Terminated
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Fondaparinux; Drug: Enoxaparin

Detailed Description

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, & platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary & secondary diagnoses, central venous access, and sequential compression device utilization.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability or legally authorized representative (LAR) to provide informed consent
2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

Exclusion Criteria:

1. Active or suspected bleeding
2. Platelet count less than 100,000 per microliter (mm3) of blood
3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
4. Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
6. Pregnancy (for medicolegal considerations)
7. Patients with or expecting to require an epidural catheter
8. Patients who are expected to have an immediate (within 24h) need for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fondaparinux; Fondaparinux treatment - one standard of care option	Drug: Fondaparinux; The dose for Arixtra is 2.5 mg once daily, subcutaneously.; Other Names: Arixtra
Active Comparator: 2; Enoxaparin	Drug: Enoxaparin; The dose for Lovenox is 40 mg once daily, subcutaneously.; Other Names: Lovenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bleeding events	inpatient hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of thrombocytopenia	inpatient hospitalization

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Charles W Callender, MD, Eastern VA Medical School, Norfolk, VA

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 27, 2007
• First Submitted That Met QC Criteria: June 27, 2007
• First Posted (Estimate): June 28, 2007

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Venous Thromboembolism Prophylaxis; VTE prophylaxis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Enoxaparin; Fondaparinux; PENTA
• Other Study ID Numbers: 107696