Treatment of Upper Extremity Deep-Vein Thrombosis
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.
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.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Deep-Vein Thrombosis
Intervention
Dalteparin sodium injection
Location
University of Oklahoma Health Science Center
Oklahoma City
Oklahoma
United States
73117
Status
Active, not recruiting
Source
University of Oklahoma
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00245856
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Upper Extremity Deep Vein Thrombosis
DEEP VEIN THROMBOSIS of an upper extremity vein (e.g., AXILLARY VEIN; SUBCLAVIAN VEIN; and JUGULAR VEINS). It is associated with mechanical factors (Upper Extremity Deep Vein Thrombosis, Primary) secondary to other anatomic factors (Upper Extremity Deep Vein Thrombosis, Secondary). Symptoms may include sudden onset of pain, warmth, redness, blueness, and swelling in the arm.
Vein Of Galen Malformations
Congenital arteriovenous malformation involving the VEIN OF GALEN, a large deep vein at the base of the brain. The rush of arterial blood directly into the vein of Galen, without passing through the CAPILLARIES, can overwhelm the heart and lead to CONGESTIVE HEART FAILURE.
Stockings, Compression
Tight coverings for the foot and leg that are worn to aid circulation in the legs and prevent the formation of EDEMA and DEEP VEIN THROMBOSIS. PNEUMATIC COMPRESSION STOCKINGS serve a similar purpose especially for bedridden patients and following surgery.
Intermittent Pneumatic Compression Devices
Instruments that generate intermittent forces, uniformed or graduated, to facilitate the emptying of VEINS. These devices are used to reduce limb EDEMA and prevent venous THROMBOEMBOLISM, such as deep vein thrombosis in the legs.
Postthrombotic Syndrome
A condition caused by one or more episodes of DEEP VEIN THROMBOSIS, usually the blood clots are lodged in the legs. Clinical features include EDEMA; PAIN; aching; heaviness; and MUSCLE CRAMP in the leg. When severe leg swelling leads to skin breakdown, it is called venous STASIS ULCER.
Clinical Trials
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
The purpose of this study is to obtain an estimate of catheter survival in the setting of upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and warfarin....
The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial
It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they m...
The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Dee...
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein...
PubMed Articles
Dalteparin in Critically Ill Patients.
To the Editor: The Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT; ClinicalTrials.gov number, NCT00182143) investigators (April 7 issue)(1) report a significantly reduced incidence of...
Dalteparin in Critically Ill Patients.
To the Editor: The Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT; ClinicalTrials.gov number, NCT00182143) investigators (April 7 issue)(1) report a significantly reduced incidence of...
Dalteparin in Critically Ill Patients.
To the Editor: The Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT; ClinicalTrials.gov number, NCT00182143) investigators (April 7 issue)(1) report a significantly reduced incidence of...
Short versus extended thromboprophylaxis after total knee arthroplasty: A randomized comparison.
INTRODUCTION: The optimal duration of thromboprophylaxis after total knee arthroplasty remains uncertain. MATERIAL AND METHODS: We performed a randomized, open trial to determine whether to stop throm...
Implementing AORN Recommended Practices for Prevention of Deep Vein Thrombosis.
One to two people per 1,000 are affected by deep vein thrombosis (DVT) or pulmonary embolism in the United States each year. AORN published its new "Recommended practices for prevention of deep vein t...
