Management of Superficial Thrombophlebitis

November 14, 2013 updated by: University of Oklahoma
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Department of Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Fragmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombosis Progression and Venous Thromboembolism (VTE)
Time Frame: Day 14
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Day 14
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.
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.
Time Frame: 3 months
Number of participants with bleeding events related to treatment
3 months
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
Day 1, Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Pfizer

Investigators

  • Principal Investigator: Suman Rathbun, M.D., University of Oklahoma Medicine/Cardiovascular Section

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (ESTIMATE)

December 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10341
  • ORA-20030415 (OTHER: University of Oklahoma Office of Research Administration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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