Superficial Thrombophlebitis Clinical Trial
Official title:
Management of Superficial Thrombophlebitis
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01245998 -
Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis
|
Phase 4 |