Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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 thromboembolic events (deep vein thrombosis and pulmonary embolism), whether efficacy of low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment), and to recognize groups of patients in which treatment with heparin is most efficient, as well as to determine factors that influence the efficacy of SVT treatment with heparin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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