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NCT00001713 · ClinicalTrials.gov registry record · Phase 1
Treatment for Blood Clots in the Veins of the Legs
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00001713 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 20 participants.
The verdict
NCT00001713, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Heparin
- DRUG Warfarin
- DRUG Recombinant Tissue Plasminogen Activator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 1998-02 |
| Est. Completion | 2006-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001713
The ClinicalTrials.gov registry entry for NCT00001713 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Heparin is the first listed.
NCT00001713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001713 about?
NCT00001713 is a clinical study titled "Treatment for Blood Clots in the Veins of the Legs". 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 ...
What is the current status of trial NCT00001713?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 1998-02. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00001713?
The interventions under investigation include: Heparin (DRUG), Warfarin (DRUG), Recombinant Tissue Plasminogen Activator (DRUG).
Who is sponsoring clinical trial NCT00001713?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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