Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy

NCT00377091 | Withdrawn Phase 4

• 1 other identifier: 0510M76771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; venous thromboembolism; pharmacoeconomic; heparin; unfractionated heparin; fondaparinux; length of stay; costs; bleeding; thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Fondaparinux DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

St. Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism; Hemorrhage; Thrombosis

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Michael P. Gulseth, Pharm. D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: June 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)