Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT00245856
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2005-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Upper Extremity Deep-Vein Thrombosis
Sponsor:
University of Oklahoma
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ORA-20020622 | OTHER | University of Oklahoma Office of Research Administration | View |