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Management of Superficial Thrombophlebitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264381
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Superficial Thrombophlebitis Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis Drug: Dalteparin sodium injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management of Superficial Thrombophlebitis
Study Start Date : October 2002
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: Ibuprofen
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
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.
Other Name: Fragmin

Primary Outcome Measures :
  1. Thrombosis Progression and Venous Thromboembolism (VTE) [ Time Frame: Day 14 ]
    Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing

  2. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264381

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United States, Oklahoma
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: Suman Rathbun, M.D. University of Oklahoma Medicine/Cardiovascular Section
Publications of Results:
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Responsible Party: University of Oklahoma Identifier: NCT00264381    
Other Study ID Numbers: 10341
ORA-20030415 ( Other Identifier: University of Oklahoma Office of Research Administration )
First Posted: December 12, 2005    Key Record Dates
Results First Posted: November 18, 2013
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by University of Oklahoma:
Superficial Thrombophlebitis
Superficial Thrombus
Superficial Phlebitis
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action