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Adult Trials: 18+ Years
- Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Management of Superficial Thrombophlebitis | |||
| Official Title ICMJE | Management of Superficial Thrombophlebitis | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Dalteparin sodium injection
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. Other Name: Fragmin | |||
| Study Arms ICMJE | Active Comparator: Ibuprofen
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol Intervention: Drug: Dalteparin sodium injection | |||
| Publications * | Rathbun SW, Aston CE, Whitsett TL. A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis. J Thromb Haemost. 2012 May;10(5):833-9. doi: 10.1111/j.1538-7836.2012.04669.x. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 72 | |||
| Original Enrollment ICMJE | 150 | |||
| Actual Study Completion Date ICMJE | September 2011 | |||
| Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00264381 | |||
| Other Study ID Numbers ICMJE | 10341 ORA-20030415 ( Other Identifier: University of Oklahoma Office of Research Administration ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | University of Oklahoma | |||
| Study Sponsor ICMJE | University of Oklahoma | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | University of Oklahoma | |||
| Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||