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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005957-23-IT

Enrollment

900

Registered

2006-03-15

Start date

2005-12-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

superficial venous thromboses MedDRA version: 6.1 Level: PT Classification code 10034902

Interventions

Trade Name: FLUXUM 6 SIR.0,4 ML 4250UI Pharmaceutical Form: Solution for injection INN or Proposed INN: Parnaparin Concentration unit: IU international unit(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026