Treatment for Blood Clots in the Veins of the Legs
Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
Summary
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional
treatment with anticoagulation therapy is effective in reducing the associated risk of
pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower
extremity. While systemic thrombolytic therapy has been shown to be more effective than
anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment
in restoring venous patency. Current treatment regimens are based on use of urokinase,
infused continuously through catheters imbedded into the thrombus. These treatment regimens
require doses on the order of 10,000,000 units of urokinase, resulting in significant
bleeding complications and prohibitive costs.
Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with
rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The
proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA
associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis
encountered in the lower extremity.
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)