Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Fondaparinux
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability or legally authorized representative (LAR) to provide informed consent 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: Active or suspected bleeding Platelet count less than 100,000 per microliter (mm3) of blood Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day) Pregnancy (for medicolegal considerations) Patients with or expecting to require an epidural catheter Patients who are expected to have an immediate (within 24h) need for surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events |  | inpatient hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of thrombocytopenia |  | inpatient hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolism Prophylaxis, VTE prophylaxis