Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Phase 3

Terminated

• Conditions: Venous Thromboembolism
• Interventions: Drug: Fondaparinux; Drug: Enoxaparin

• Registration Number: NCT00493896
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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

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 Timeline

• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Study Start: 2007-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fondaparinux	Fondaparinux	Fondaparinux treatment - one standard of care option
2	Enoxaparin	Enoxaparin

Primary Outcome Measures

Name	Time	Method
Bleeding events	inpatient hospitalization

Secondary Outcome Measures

Name	Time	Method
Development of thrombocytopenia	inpatient hospitalization