Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245856
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2005-10-26
Brief Title:
Treatment of Upper Extremity Deep-Vein Thrombosis
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Treatment of Upper Extremity Deep-Vein Thrombosis
Status:
COMPLETED
Status Verified Date:
2013-02
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:
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin dalteparin sodium injection for three months
Detailed Description:
Upper extremity deep-vein thrombosis DVT is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36 of cases including fatal embolism The major risk factor for development of DVT is presence of a central venous catheter in which up to 30 of patients may develop venous thrombosis Peripherally inserted central catheters or PICC lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion There is little data on the incidence of DVT with these catheters or effective treatment regimen
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin dalteparin sodium injection for three months About 100 patients will be enrolled in this study at the University of Oklahoma
All patients with upper extremity DVT will be screened Each will have a complete baseline and risk factor assessment
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound
All patients will participate for a period of 12 months with follow up visits at 5-7 day and 1 3 6 12 months
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin dalteparin sodium injection for three months About 100 patients will be enrolled in this study at the University of Oklahoma
All patients with upper extremity DVT will be screened Each will have a complete baseline and risk factor assessment
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound
All patients will participate for a period of 12 months with follow up visits at 5-7 day and 1 3 6 12 months
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 |
|---|---|---|---|
| ORA-20020622 | OTHER | University of Oklahoma Office of Research Administration | None |