Contact:Elaine Dube
Phone:(434)924-9199
E-mail:ed7y@Virginia.EDU
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.
Participant's 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.
|
|
Primary Investigator: Macik B. Gail,