Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis

NCT01245998 | Completed Phase 4 DMC

• 1 other identifier: REVETR2010
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Superficial Thrombophlebitis

Keywords

Thrombophlebitis; Venous thrombosis; Pulmonary embolism; Anticoagulants; Low-Molecular-Weight Heparin

Outcome Measures

Primary Outcomes (3)

• To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST

  To compare the efficacy of therapeutic vs. preventive doses of dalteparin in prevention of thromboembolic complications and disease progression in patients with acute thrombophlebitis of lower extremities

  3 months

• Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST

  3 months

• Clinically relevant bleeding occurring

  (i.e., major or clinically relevant non-major bleeding)

  during treatment

Secondary Outcomes (4)

• To investigate the safety of ST treatment with preventive doses of dalteparin compared with therapeutic doses, death, bleeding, heparin-induced thrombocytopenia (HIT)

  3 months

• To ascertain whether the extent or progression of ST is related to systemic inflammatory parameters

  12 months

• To study a possible correlation between effectiveness of treatment of ST with preventive and therapeutic doses of dalteparin and severity of systemic inflammatory parameters.

  12 months

• To determine whether the extension of anticoagulant treatment with the study drug for additional six weeks is more effective and safer

  3 months

Study Arms (2)

dalteparin 5000 I.U./24 h s.c.

ACTIVE COMPARATOR

Drug: Dalteparin

dalteparin 15000 I.U./24 h s.c.

ACTIVE COMPARATOR

Drug: Dalteparin

Interventions

Dalteparin DRUG

dalteparin 5000 I.U./24 h s.c. for 6 weeks

Also known as: Fragmin

dalteparin 5000 I.U./24 h s.c.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Spirkoska A, Jezovnik MK, Poredos P. Time course and the recanalization rate of superficial vein thrombosis treated with low-molecular-weight heparin. Angiology. 2015 Apr;66(4):381-6. doi: 10.1177/0003319714533183. Epub 2014 May 7.

  PMID: 24807875 RESULT

MeSH Terms

Conditions

Thrombophlebitis; Venous Thrombosis; Pulmonary Embolism

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Phlebitis; Peripheral Vascular Diseases; Vasculitis; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Pavel Poredos, M.D., Ph.D.

  University Medical Centre Ljubljana, Department of Vascular Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor tenure track, board certified in internal medicine, cardiology and vascular disease, head of the research department

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: December 1, 2010
• Primary Completion: December 3, 2012
• Study Completion: January 1, 2014
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

SL (1)