Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

This study is not yet open for participant recruitment.

Verified by Eastern Virginia Medical School, June 2007

First Received: June 27, 2007 No Changes Posted

Sponsors and Collaborators:	Eastern Virginia Medical School GlaxoSmithKline
Information provided by:	Eastern Virginia Medical School
ClinicalTrials.gov Identifier:	NCT00493896

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	Phase III

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:

Bleeding events [ Time Frame: inpatient hospitalization ]

Secondary Outcome Measures:

Development of thrombocytopenia [ Time Frame: inpatient hospitalization ]

Estimated Enrollment:	100
Study Start Date:	July 2007

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493896

Contacts

Contact: Charles W Callender, MD	757-446-8910	callencw@evms.edu
Contact: Dominick A Rascona, MD	757-953-2079	Dominick.Rascona@med.navy.mil

Locations

United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507

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

Study ID Numbers:	107696
Study First Received:	June 27, 2007
Last Updated:	June 27, 2007
ClinicalTrials.gov Identifier:	NCT00493896 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:

Venous Thromboembolism Prophylaxis
VTE prophylaxis

Study placed in the following topic categories:

Fibrin Modulating Agents
Embolism and Thrombosis
Anticoagulants
Embolism
Vascular Diseases
Fibrinolytic Agents

Fondaparinux
Cardiovascular Agents
Venous Thromboembolism
Org 31540
Thrombosis
Thromboembolism

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fondaparinux
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism

Thromboembolism
Thrombosis
Org 31540
Pharmacologic Actions
Fibrin Modulating Agents
Embolism and Thrombosis
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009