Management of Superficial Thrombophlebitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management of Superficial Thrombophlebitis

Conditions
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Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis

Intervention / Treatment
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* Drug: Dalteparin sodium injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol | Drug: Dalteparin sodium injection<br>* 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.<br>* Other names: Fragmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis Progression and Venous Thromboembolism (VTE) | Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing | Day 14 | 
| Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | Number of participants with bleeding events related to treatment | 3 months | 
| Change From Baseline to Day 14 in Pain Assessment | 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 | Day 1, Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Thrombophlebitis, STP, Fragmin, Ibuprofen, Superficial Thrombus, Superficial Phlebitis, phlebitis