Clinical trial NCT00264381: Management of Superficial Thrombophlebitis
Official title: Management of Superficial Thrombophlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Superficial Thrombophlebitis
Upper Extremity Superficial Thrombophlebitis
Lower Extremity Superficial Thrombophlebitis
Keywords: Superficial Thrombophlebitis
STP
Fragmin
Ibuprofen
Superficial Thrombus
Superficial Phlebitis
phlebitis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-12-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Thrombosis Progression and Venous Thromboembolism (VTE)
timeFrame: Day 14
measure: Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.
timeFrame: 3 months
measure: Change From Baseline to Day 14 in Pain Assessment
timeFrame: Day 1, Day 14
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Department of Veterans Affairs Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Medicine/Cardiovascular Section
name: Suman Rathbun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.