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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: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00001713 record still lists
NCT00001713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Heparin is the first listed.
NCT00001713 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001713's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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