Status:
COMPLETED
Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Thrombophlebitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT00362947
Start Date
August 1 2006
End Date
February 1 2011
Last Update
March 19 2021
Active Locations (2)
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1
Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi
Bologna, BO, Italy, 40138
2
U.O. Medicina Critica
Piacenza, PC, Italy, 29100