NCT00264381

Management of Superficial Thrombophlebitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).

Detailed description

Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism. Current standard therapy for STP consists of local heat, elevation of the extremity, and non-steroidal anti-inflammatory medication. However, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of STP in many patients. The purpose of this study is to document the outcome of patients with objectively documented STP who are treated with NSAID therapy (standard care) verses those treated with low-molecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen. All patients with documented upper or lower STP will be screened. Each will have a complete baseline and risk factor assessment. All patients will be randomized in one of two treatment groups: (a) Experimental group who will receive Fragmin (dalteparin)fixed dose subcutaneously daily for 7 days or (b) Control group who will receive ibuprofen 800mg given orally three times daily for 7 days. All patients will receive study drug for a period of 1-2 weeks with reassessment of STP by ultrasound. All patients will participate for a period of 3 months with follow up visits at 7-9, and 14-16 day, and 1,3 months.

Conditions

• Superficial Thrombophlebitis
• Upper Extremity Superficial Thrombophlebitis
• Lower Extremity Superficial Thrombophlebitis

Interventions

Type	Name	Description
DRUG	Dalteparin sodium injection	Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.

Timeline

• Start date: 2002-10-01
• Primary completion: 2009-09-01
• Completion: 2011-09-01
• First posted: 2005-12-12
• Last updated: 2013-11-18
• Results posted: 2013-11-18

Locations

2 sites across 1 country: United States