Management of Superficial Thrombophlebitis

University of Oklahoma (OU)

Status and phase: Completed; Phase 4

Conditions: Lower Extremity Superficial Thrombophlebitis; Superficial Thrombophlebitis; Upper Extremity Superficial Thrombophlebitis

Treatments: Drug: Dalteparin sodium injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00264381

ORA-20030415 (Other Identifier)

10341

Details and patient eligibility

About

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).

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 1 patient group

Ibuprofen

Active Comparator group

Description:

Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol

Treatment:

Drug: Dalteparin sodium injection