Treatment of Upper Extremity Deep-Vein Thrombosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep-Vein Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment of Upper Extremity DVT

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

Group Type EXPERIMENTAL

Dalteparin sodium injection

Intervention Type DRUG

200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.

Warfarin

Intervention Type DRUG

Titrated to INR 2-3 through study month 3

Interventions

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Dalteparin sodium injection

200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.

Intervention Type DRUG

Warfarin

Titrated to INR 2-3 through study month 3

Intervention Type DRUG

Other Intervention Names

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Fragmin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No