Clinical Trial: Management of Superficial Thrombophlebitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Management of Superficial Thrombophlebitis

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 Summary:

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.

Sponsor: University of Oklahoma

Current Primary Outcome:

• Thrombosis Progression and Venous Thromboembolism (VTE) [ Time Frame: Day 14 ]
  Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
• Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months [ Time Frame: 3 months ]
  Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.

Original Primary Outcome: The primary outcome measure will be the degree of thrombus extension or symptomatically confirmed deep-vein thrombosis as assessed by objective ultrasound imaging on day 7-9 and 14-16.

Current Secondary Outcome:

• Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. [ Time Frame: 3 months ]
  Number of participants with bleeding events related to treatment
• Change From Baseline to Day 14 in Pain Assessment [ Time Frame: 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

Original Secondary Outcome: The secondary outcome measure will be improvement in pain as assessed by daily visual analog pain scale. Additional secondary outcome measure include major and minor bleeding secondary to dalteparin and ibuprofen treatment during the 3 month follow up.

Information By: University of Oklahoma

Dates:
Date Received: December 8, 2005
Date Started: October 2002
Date Completion:
Last Updated: November 14, 2013
Last Verified: November 2013