Management of Superficial Thrombophlebitis

Superficial Thrombophlebitis Clinical Trial

Official title:

Management of Superficial Thrombophlebitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264381
• Other study ID #: 10341
• Secondary ID: ORA-20030415
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2005
• Last updated: November 14, 2013
• Start date: October 2002
• Est. completion date: September 2011

Study information

• Verified date: November 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Extremity Superficial Thrombophlebitis
• Superficial Thrombophlebitis
• Thrombophlebitis
• Upper Extremity Superficial Thrombophlebitis

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Medical Center	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rathbun SW, Aston CE, Whitsett TL. A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis. J Thromb Haemost. 2012 May;10(5):833-9. doi: 10.1111/j.1538-7836.2012.04669.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis Progression and Venous Thromboembolism (VTE)	Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing	Day 14	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No