Treatment of Upper Extremity Deep-Vein Thrombosis

University of Oklahoma (OU)

Status and phase: Completed; Phase 4

Conditions: Deep-Vein Thrombosis

Treatments: Drug: Warfarin; Drug: Dalteparin sodium injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00245856

ORA-20020622 (Other Identifier)

10206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram

Exclusion criteria

• Active, clinically significant bleeding
• Known hypersensitivity to heparin or low-molecular weight heparin
• Currently pregnant or less than 1 week post-partum
• Acquired bleeding diathesis
• Known inherited bleeding disorder
• Renal failure
• Extremes of weight
• Poor performance status
• Unable to return for repeat diagnostic testing or follow-up visits

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Treatment of Upper Extremity DVT

Experimental group

Description:

Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT

Treatment:

Drug: Dalteparin sodium injection

Drug: Warfarin