RANDOMIZED CLINICAL STUDY OF DIFFERENT DOSES And DURATION OF PARNAPARINA In the TREATMENT Of SUPERFICIAL VENOUS THROMBOSIS - STEFLUX STUDY - STEFLUX

• Conditions: superficial venous thromboses; MedDRA version: 6.1Level: PTClassification code 10034902

• Registration Number: EUCTR2005-005957-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Age 18 years weight 50 kg and inferior to 110 kg TVS of the large v. safena extended in order at least 5 cm TVS of the small v. safena extended in order at least 5 cm collaterals TVS of large v. safena in the thigh extended in order at least 5 cm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age 85 years TVS of large saphena that catches up the zone from the safeno-femoral cross or for which it is indicated the oral anticoagulating therapy or the cross safeno-femoral ligature TVS of the small saphena that catches up the cross safeno-poplitea or for which it is indicated the oral anticoagulating therapy Documented proximal TVP or distal TVP or pulmonary embolism Secondary TVS to sclerotherapy Pregnancy and puerperium Arterial hypertension not controlled systolic 180 mmHg and diastolic PA 110 mmHg Active or past peptic ulcer Bacterial endocarditis Ictus in the previous 3 months haemorrhagic diathesis Piastrinopenia platelet 100,000/ L Hypersensitivity to heparin or induced history of piastrinopenia from heparin Creatininemia 2 mg 180 mol/L Contraindications to elastic stockings or compressivo handwraps Anticoagulating or heparinic therapy in the previous 72 hours Active cancer or chemotherapeutic or radiotherapeutic treatment Refusal of the informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and the safety of three different plans, different for duration and dose, of parnaparina in the treatment of the superficial venous thromboses of the inferior limbs.;Secondary Objective: To evaluate the efficacy of therapeutic doses of parnaparin for 10 gg regarding protective or therapeutic doses of parnaparina for 30 gg in reducing 1- the local symptoms 2- the risk of local and deep TVP and/orEP extension in superficial venous thromboses of the inferior limbs.;Primary end point(s): Composite end-point of symptomatic and asymptomatic TVP , relapsing and/or local extension of symptomatic TVS and EP to 30 days