Management of Superficial Thrombophlebitis
- Conditions
- Superficial ThrombophlebitisUpper Extremity Superficial ThrombophlebitisLower Extremity Superficial Thrombophlebitis
- Interventions
- Registration Number
- NCT00264381
- Lead Sponsor
- University of Oklahoma
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging
- Active, clinically significant bleeding
- Known hypersensitivity to NSAIDS, heparin or derivatives
- Currently pregnant or < 1 week post-partum
- Acquired bleeding diathesis
- Known inherited bleeding disorder
- Renal failure
- Extremes of weight
- unable to return for repeat diagnostic testing or follow-up visit
- Concurrent deep-vein thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibuprofen Dalteparin sodium injection Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
- Primary Outcome Measures
Name Time Method Thrombosis Progression and Venous Thromboembolism (VTE) Day 14 Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months 3 months Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Day 14 in Pain Assessment Day 1, Day 14 Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain
Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. 3 months Number of participants with bleeding events related to treatment
Trial Locations
- Locations (2)
Department of Veterans Affairs Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States