Management of Superficial Thrombophlebitis
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Management of Superficial Thrombophlebitis |
- 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 ]
- 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 ]
| Enrollment: | 72 |
| Study Start Date: | October 2002 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
-
Drug: Dalteparin sodium injection
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 |
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| 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 | |
| Principal Investigator: | Suman Rathbun, M.D. | University of Oklahoma Medicine/Cardiovascular Section |
More Information
No publications provided by University of Oklahoma
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Suman Rathbun, Professor of Medicine, University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00264381 History of Changes |
| Other Study ID Numbers: | 10341, ORA-20030415 |
| Study First Received: | December 8, 2005 |
| Last Updated: | February 27, 2012 |
| 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:
|
Thrombophlebitis Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Phlebitis Peripheral Vascular Diseases Vasculitis Dalteparin |
Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013