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Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

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ClinicalTrials.gov Identifier: NCT00493896
Recruitment Status : Terminated (low enrollment)
First Posted : June 28, 2007
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Fondaparinux Drug: Enoxaparin Phase 3

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  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
Study Start Date : July 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Arixtra
Active Comparator: 2
Enoxaparin
Drug: Enoxaparin
The dose for Lovenox is 40 mg once daily, subcutaneously.
Other Name: Lovenox



Primary Outcome Measures :
  1. Bleeding events [ Time Frame: inpatient hospitalization ]

Secondary Outcome Measures :
  1. Development of thrombocytopenia [ Time Frame: inpatient hospitalization ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493896


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

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00493896     History of Changes
Other Study ID Numbers: 107696
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: September 2012

Keywords provided by Eastern Virginia Medical School:
Venous Thromboembolism Prophylaxis
VTE prophylaxis

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Enoxaparin
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents