Management of Superficial Thrombophlebitis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00264381
First received: December 8, 2005
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Superficial Thrombophlebitis
Upper Extremity Superficial Thrombophlebitis
Lower Extremity Superficial Thrombophlebitis
Drug: Dalteparin sodium injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management of Superficial Thrombophlebitis

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Thrombosis Progression and Venous Thromboembolism (VTE) [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.


Secondary Outcome Measures:
  • Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of participants with bleeding events related to treatment

  • Change From Baseline to Day 14 in Pain Assessment [ Time Frame: Day 1, Day 14 ] [ Designated as safety issue: No ]
    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


Enrollment: 72
Study Start Date: October 2002
Study Completion Date: September 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264381

Locations
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Pfizer
Investigators
Principal Investigator: Suman Rathbun, M.D. University of Oklahoma Medicine/Cardiovascular Section
  More Information

Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00264381     History of Changes
Other Study ID Numbers: 10341, ORA-20030415
Study First Received: December 8, 2005
Results First Received: November 14, 2013
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Superficial Thrombophlebitis
STP
Fragmin
Ibuprofen
Superficial Thrombus
Superficial Phlebitis
phlebitis

Additional relevant MeSH terms:
Thrombophlebitis
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Dalteparin
Heparin, Low-Molecular-Weight
Ibuprofen
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014