DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Management of Superficial Thrombophlebitis

Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Superficial Thrombophlebitis; Upper Extremity Superficial Thrombophlebitis; Lower Extremity Superficial Thrombophlebitis

Intervention: Dalteparin sodium injection (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
Suman Rathbun, M.D., Principal Investigator, Affiliation: University of Oklahoma Medicine/Cardiovascular Section

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).

Clinical Details

Official title: Management of Superficial Thrombophlebitis

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

Primary outcome:

Thrombosis Progression and Venous Thromboembolism (VTE)

Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months

Secondary outcome:

Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.

Change From Baseline to Day 14 in Pain Assessment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Veterans Affairs Medical Center, Oklahoma City, Oklahoma 73104, United States

University of Oklahoma Health Science Center, Oklahoma City, Oklahoma 73104, United States

Additional Information

Starting date: October 2002
Last updated: November 14, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017