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Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

This study has been terminated.
(low enrollment)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT00493896
First received: June 27, 2007
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Venous Thromboembolism
 Drug: Fondaparinux
Drug: Enoxaparin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Bleeding events [ Time Frame: inpatient hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Development of thrombocytopenia [ Time Frame: inpatient hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493896

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

No publications provided

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00493896     History of Changes
Other Study ID Numbers: 107696
Study First Received: June 27, 2007
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Fondaparinux
PENTA
 Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013