Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis (NCT01245998) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis
Slovenia68 participantsStarted 2010-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST
Timeframe: 3 months
2
Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST