Phase 4
N=72
Management of Superficial Thrombophlebitis
Superficial Thrombophlebitis · Upper Extremity Superficial Thrombophlebitis · Lower Extremity Superficial Thrombophlebitis
Bottom Line
View on ClinicalTrials.gov: NCT00264381 ↗Enrolled (actual)
72
Serious AEs
1.4%
Results posted
Nov 2013
Primary outcome: Primary: Thrombosis Progression and Venous Thromboembolism (VTE) — 4; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dalteparin sodium injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombosis Progression and Venous Thromboembolism (VTE) |
4; 0; 0; 0 | — |
| PRIMARY Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months |
6; 4; 0; 1 | — |
| SECONDARY Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. |
0; 0 | — |
| SECONDARY Change From Baseline to Day 14 in Pain Assessment |
-2.28; -2.23 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT00264381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.