Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001713
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Treatment for Blood Clots in the Veins of the Legs
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Acute Deep Vein Thrombosis of the Lower Extremity With Intraclot Pulse-Sprayed Recombinant Tissue Plasminogen Activator Plus Heparin and Warfarin A Pilot Study
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10000000 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
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
Detailed Description:
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 10000000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-CC-0067 | None | None | None |