Management of Superficial Thrombophlebitis - Full Text View

Sponsor:	University of Oklahoma
Collaborator:	Pfizer
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00264381

Purpose

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).

Condition	Intervention	Phase
Superficial Thrombophlebitis Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis	Drug: Dalteparin sodium injection	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Management of Superficial Thrombophlebitis

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

The primary outcome measure will be the degree of thrombus extension or symptomatically confirmed deep-vein thrombosis as assessed by objective ultrasound imaging on day 7-9 and 14-16. [ Time Frame: 7 - 9 days, followed by 14-16 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome measure will be improvement in pain as assessed by daily visual analog pain scale. Additional secondary outcome measure include major and minor bleeding secondary to dalteparin and ibuprofen treatment during the 3 month follow up. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2002
Estimated Study Completion Date:	September 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264381

Locations

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

Sponsors and Collaborators

University of Oklahoma

Pfizer

Investigators

Principal Investigator:

Suman Rathbun, M.D.

University of Oklahoma Medicine/Cardiovascular Section

More Information

No publications provided

Responsible Party:	University of Oklahoma ( Suman W. Rathbun, M.D./ Priniciple Investigator )
Study ID Numbers:	10341, ORA-20030415
Study First Received:	December 8, 2005
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00264381 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Oklahoma:

Superficial Thrombophlebitis
STP
Fragmin
Ibuprofen

Superficial Thrombus
Superficial Phlebitis
phlebitis

Additional relevant MeSH terms:

Anticoagulants
Peripheral Vascular Diseases
Vasculitis
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Thrombosis
Embolism and Thrombosis
Fibrin Modulating Agents
Dalteparin
Therapeutic Uses
Phlebitis
Venous Thrombosis
Cardiovascular Diseases
Thrombophlebitis

ClinicalTrials.gov processed this record on February 08, 2010