Thrombophlebitis
Conditions
Keywords
Superficial vein thrombosis, thrombophlebitis, LMWH, parnaparin
Brief summary
The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.
Detailed description
Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study. Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes: A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.
Interventions
DRUGLMWH parnaparin subcutaneously
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Weight \> 50 kg and less than 110 kg * SVT of the grand saphenous vein for at least 4 cm * SVT of the small saphenous vein for at least 4 cm * Collateral SVT of the large saphenous vein of the thigh for at least 4cm
Exclusion criteria
* SVT of the grand saphenous vein reaching the saphenofemoral cross (within 3 cm) * SVT of the small saphenous vein reaching the saphenopopliteal cross * Documented proximal or distal DVT or pulmonary embolism * SVT secondary to sclerotherapy * Pregnancy and puerperium * uncontrolled arterial hypertension (Systolic pressure \> 180 mmHg and diastolic pressure \> 110 mmHg) * Active peptic ulcer * Bacterial endocarditis * Stroke in the previous 3 months * Haemorrhagic diathesis * Thrombocytopenia (platelets \< 100,000/ µL) * Hypersensitivity to heparin or history of thrombocytopenia induced by heparin * Creatinine \> 2 mg% (\> 180 µmol/L) * Heparin therapy (any dose) or anticoagulant therapy for longer than the previous 72 hours * In-hospital development of SVT * Previous saphenectomy by any method * Surgery in the previous 30 days * Serious liver disease * Use of dextran, mannitol, thrombolytic treatment, chronic use of NSAID and cortisone-based drugs. * Active cancer or under chemotherapy or radiotherapy * Thrombectomy of superficial vein involved * Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness objectives | 33 days | composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days. |
| Major bleeding | 33 | Bleeding events were defined as major if retroperitoneal, intracranial, intraocular with severe vision damage, intra-articular, intra-abdominal of upper or lower digestive tract, genito-urinary tract, respiratory tract or associated with a decrease in the haemoglobin of ≥ 2.0 g/dL, or if requiring transfusion of ≥2 units of blood or if fatal. Bleeding was classified as minor in all other cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary effectiveness objectives | 93 | i)- reduction in local symptoms during treatment and ii)- the combined efficacy end-point during a follow-up of 93 days after the start of treatment. |
| secondary outcome for safety | 33 | the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions). |
Countries
Italy
Outcome results
None listed