The objective of the study is to evaluate thrombolytic therapy using recombinant tissue plasminogen activator (rtPA) for treatment of acute deep vein thrombosis of the lower extremity. While the conventional therapy, anticoagulation alone, is highly effective in prevention of life threatening pulmonary embolism, it does not preserve venous function in the affected leg, often leading to postphlebitic syndromes in subsequent years. The study is designed to evaluate efficacy, safety, and cost of this form of treatment for restoration of venous function in the lower extremity. Since start of the study, 14 patients have been treated. All except one patient had significant improvement. Only two patients have had evidence of small pulmonary emboli during treatment, detected on ventilation perfusion lung scans that are obtained in all patients accepted into the protocol. None of these patients were clinically symptomatic. One patient developed a non-life-threatening biceps hematoma probably induced by automatic blood pressure monitoring during the rtPA treatment. No patients have required blood transfusions and no other complications have occurred.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL000077-05
Application #
6674032
Study Section
(DRD)
Project Start
Project End
Budget Start
Budget End
Support Year
5
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code