Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy - Full Text View

Sponsors and Collaborators:	University of Minnesota GlaxoSmithKline
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00377091

Purpose

This study compares two blood thinners which are both accepted standard cares, fondaparinux and unfractionated heparin (UFH). These drugs are used to prevent the growth of existing blood clots and formation of additional blood clots in patients with pulmonary embolism (a blood clot in the lung) as they are beginning to take warfarin (another standard care blood thinner). Patients will be invited to participate because they have been diagnosed with a pulmonary embolism, require anticoagulation therapy (treatment with a blood thinner), and are currently hospitalized.

The purpose of this study is to determine if patients treated with fondaparinux will have shorter hospital stays and lower costs of treatment while in the hospital than similar patients receiving a different standard care with UFH. Fondaparinux is already approved by the FDA for use in patients with pulmonary embolism, for both inpatient and outpatient care, as long as treatment is begun with warfarin while they are hospitalized. It is therefore not an experimental treatment. The study is being conducted to determine which FDA approved treatment is the best practice for hospital treatment of pulmonary embolism. The study will also examine the safety and effectiveness of fondaparinux in local use.

Condition	Intervention	Phase
Pulmonary Embolism	Drug: Fondaparinux	Phase IV

MedlinePlus related topics: Blood Thinners Pulmonary Embolism

Drug Information available for: Fondaparinux sodium ORG 31540 Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Pharmacoeconomic Evaluation of Fondaparinux Treatment of Pulmonary Embolism (PE) Compared to Treatment With Unfractionated Heparin

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

Primary endpoints: The primary end-points will be determining if the utilization of fondaparinux to treat PE in the inpatient setting will reduce length of stay and hospital treatment costs, when compared to a UFH matched control group.

Secondary Outcome Measures:

Secondary endpoints: The secondary end-points will be to determine if bleeding and recurrent thrombosis rates are similar between the fondaparinux cohort and the UFH matched control group.

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2007

Detailed Description:

Research Question

This study is being conducted to determine if treatment of pulmonary embolism (PE) with fondaparinux will decrease the length of stay and hospital costs of therapy while maintaining safety and efficacy, when compared to unfractionated heparin (UFH). Primary research questions: Determine if PE treatment utilizing fondaparinux will reduce the inpatient length of stay (LOS) and costs of hospital care to St. Mary's Duluth Clinic Health System (SMDC), when compared to a matched group of patients treated with UFH as standard care, during the same time period. Secondary research questions: Determine if bleeding and recurrent thrombosis rates are similar between the fondaparinux cohort and the UFH matched control group.

Specific Aims

Enroll 30 St. Mary's Medical Center (SMMC, an affiliate of SMDC) patients into the treatment cohort, utilizing fondaparinux as their primary immediate antithrombin therapy, while warfarin is being titrated to therapeutic effect.
Retrospectively identify a matched control group of 30 PE patients, treated with UFH as standard care, during the same period of time.
Determine the LOS and costs of inpatient care on a standardized scale for both the treatment cohort and the control group.
Perform a retrospective review of patients' medical records for the 3 months after the initial pulmonary embolism, to determine the rates of:

4a. repeat venous thromboembolism events (VTE) 4b. bleeding events

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 years of age or older who present with acute symptomatic pulmonary embolism and who require antithrombotic therapy
Diagnostic confirmation based on the following criteria
1. intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography
2. a high-probability ventilation-perfusion lung scan, or a nondiagnostic lung scan with documentation of deep-vein thrombosis, either by compression ultrasonography or by venography.
Primary outpatient MD of record is an SMDC MD or patient did not have an outpatient MD when this event occurred.
For the matched control (UFH) cohort only: unfractionated heparin utilized for initial antithrombotic therapy. (LMWH use is allowed initially in the fondaparinux arm.) Patient willingness to have fondaparinux injections administered as an outpatient by themselves, family members, or other caregivers.

Exclusion Criteria:

Patients will be ineligible for the study if they had received therapeutic doses of UFH or LMWH or oral anticoagulants for more than 24 hours;
Patient required thrombolysis, embolectomy, or a vena cava filter;
Anticoagulant therapy was contraindicated - for example, because of active bleeding or thrombocytopenia (a platelet count below 100,000 per cubic millimeter).
Patients are ineligible if they had an estimated creatinine clearance < 30 mL/min.
Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg);
Pregnancy
Physician has estimated the life expectancy to be less than three months.
Patients weighing > 150 kg
Indwelling epidural catheter
Inability to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377091

Locations

United States, Minnesota
St. Mary's Medical Center
Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

University of Minnesota

GlaxoSmithKline

Investigators

Principal Investigator:

Michael P. Gulseth, Pharm. D.

University of Minnesota

More Information

Study ID Numbers:	0510M76771
Study First Received:	September 13, 2006
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00377091
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

pulmonary embolism
venous thromboembolism
pharmacoeconomic
heparin
unfractionated heparin

fondaparinux
length of stay
costs
bleeding
thrombosis

Study placed in the following topic categories:

Pulmonary Embolism
Heparin, Low-Molecular-Weight
Vascular Diseases
Fondaparinux
Venous Thromboembolism
Hemorrhage
Thrombosis
Thromboembolism

Org 31540
Calcium heparin
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009