Treatment for Blood Clots in the Veins of the Legs (NCT00001713) | Clinical Trial Compass
CompletedPhase 1
Treatment for Blood Clots in the Veins of the Legs
United States20 participantsStarted 1998-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
Patients must be 18 years or older. A negative pregnancy test is required for all female patients of child-bearing age.
Only patients with first onset acute DVT will be accepted. Acute DVT-LE must be documented by ultrasonography or venogram and will be defined as thrombosis of a major deep vein segment above the popliteal vein less than 14 days since onset of symptoms or diagnosis. Extension of thrombosis from the popliteal vein into calf veins is acceptable, but isolated calf vein thrombosis will not be treated under this protocol, as the benefits of thrombolytic therapy do not outweigh the risks.
EXCLUSION CRITERIA:
Current familial or acquired bleeding diathesis not attributable to heparin (prothrombin time greater than 15 s, a PTT greater than 36 s, fibrinogen less than 150 mg/dL); platelet count less than 50,000/gL unsupportable with platelet transfusions; creatinine greater than 2 mg/dL; severe hypertension (systolic greater than 200 mm Hg, or diastolic greater than 100 mm Hg); atrial fibrillation; known right-to-left shunts; pregnancy; breast feeding; history of anaphylactic reactions to contrast media; history or evidence of heparin-induced thrombocytopenia. Patients with underlying coagulopathy must be evaluated and cleared by Dr. Horne or a consulting NIH hematologist before they can be accepted for the treatment protocol.
Any of the following within the previous 2 weeks: gastrointestinal hemorrhage, active peptic ulcer disease, hemoptysis,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001713
SponsorNational Institutes of Health Clinical Center (CC)