Status:
COMPLETED
Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Superficial Thrombophlebitis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The aim of the study is to establish whether treatment of superficial vein thrombosis (SVT) with low-molecular-weight heparin in preventive or therapeutic doses prevents disease progression and thromb...
Detailed Description
Until recently thrombophlebitis was regarded as a benign and self-limiting disease. Recent studies have shown that various complications, especially vein thrombosis and pulmonary thromboembolism, ofte...
Eligibility Criteria
Inclusion
- written informed consent to participate in the study
- symptomatic thrombophlebitis of the great saphenous vein measuring at least 10 cm or the small saphenous vein measuring at least 10 cm or a collateral of the great saphenous vein measuring at least 10 cm (within 7 days from the onset of the disease)
- age 18 to 85 years
- body weight 65 to 85 kg
Exclusion
- inability to objectively confirm the diagnosis
- excessive or insufficient body weight (more than 85 kg or less than 60 kg)
- history of previous thromboembolic complications (including previous thrombophlebitis, vein thrombosis and pulmonary embolism)
- contraindications for anticoagulant treatment
- active bleeding or high risk for bleeding contraindicating treatment with (LMWH)
- diseases requiring anticoagulant treatment
- proximal or distal deep vein thrombosis or pulmonary embolism (either symptomatic or incidentally found asymptomatic)
- thrombophlebitis of the great saphenous vein at a distance of less than 5 cm from the saphenofemoral junction or thrombophlebitis of small saphenous vein at a distance of less than 3 cm from the saphenopopliteal junction
- thrombophlebitis that might arise as a consequence of a previous intravenous access (infusion thrombophlebitis), sclerotherapy or surgical treatment of chronic vein insufficiency
- pregnancy, known malignant disease or chemotherapy
- immobility
- advanced stage of kidney failure (GF \< 30 mL/min/1.72 m2)
- significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01245998
Start Date
December 1 2010
End Date
January 1 2014
Last Update
May 4 2018
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000