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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Thrombosis

Trial Information

Men and Women age 18 or older with active malignancy and a newly diagnosed deep-vein thrombosis

UVa Health System, Department of Hematology-Oncology; Hematology Division, seeks Men and Women ages 18 or older with active malignancy and a newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both, for research study. Deep-vein thrombosis occurs when a blood clot forms in a vein buried deep within muscle tissue. A pulmonary embolism is a blood clot that blocks an artery delivering blood to the lungs and is a possible result of deep-vein thrombosis.

The purpose of the study is to determine the rate of major bleeding events in study participants with cancer who are receiving extended treatment with an investigational drug FRAGMIN® for the prevention of thromboembolism (VTE). Thromboembolism occurs when a blood clot breaks loose, travels through the blood stream, and blocks a blood vessel. Study involves physical examinations, standard blood tests, Electrocardiograms, CT scans, MRI or Ultrasound, injections of FRAGMIN®, and blood pregnancy tests for women of childbearing potential. Participation in this study will require a maximum of 16 study visits over 52 weeks. The screening visit will generally last 3-4 hours and may occur over two days. Each additional study visit will last about 1-2 hours.

All necessary study-related supplies including FRAGMIN®, needles, physical examinations, blood collection, and medical care will be provided free of charge.
Participants insurance company will be billed for any tests or care given beyond what is required in the study. Other drugs or treatments given to help control side effects will be billed to the insurance company. Participants must cover any costs not covered by the insurance company.
No compensation is provided for this study.

Contact Information:
For more information please contact:
Elaine Dube
Phone: (434) 924-9199 email: ed7y@virginia.edu
IRB-HSR# 14288

Principal Investigator: B. Gail Macik, M.D.



www.healthsystem.virginia.edu/clinical_trials

Elaine Dube
University of Virginia
School of Medicine
Hematology/Oncology, Internal Medicine
Charlottesville, VA 22908
Phone: 434-924-9199
Fax: --
EMail: ed7y@Virginia.EDU

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