Management of Superficial Thrombophlebitis

Management of Superficial Thrombophlebitis

Sponsors

Lead Sponsor: University of Oklahoma

Collaborator: Pfizer

Source University of Oklahoma
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.

Overall Status Completed
Start Date October 2002
Completion Date September 2011
Primary Completion Date September 2009
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Thrombosis Progression and Venous Thromboembolism (VTE) Day 14
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months 3 months
Secondary Outcome
Measure Time Frame
Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. 3 months
Change From Baseline to Day 14 in Pain Assessment Day 1, Day 14
Enrollment 72
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dalteparin sodium injection

Description: 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.

Arm Group Label: Ibuprofen

Other Name: Fragmin

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Suman Rathbun, M.D. Principal Investigator University of Oklahoma Medicine/Cardiovascular Section
Location
Facility:
Department of Veterans Affairs Medical Center | Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Science Center | Oklahoma City, Oklahoma, 73104, United States
Location Countries

United States

Verification Date

November 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ibuprofen

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov