Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis
Overview
- Phase
- Phase 3
- Intervention
- LMWH parnaparin subcutaneously
- Conditions
- Thrombophlebitis
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 664
- Locations
- 2
- Primary Endpoint
- Primary effectiveness objectives
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
GUALTIERO PALARETI
Prof.Gualtiero Palareti
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
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
Arms & Interventions
A
A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days
Intervention: LMWH parnaparin subcutaneously
B
B - Parnaparin 8.500 UI aXa od for 10 days followed by 6.400 UI aXa once daily (intermediate therapeutic doses) for 20 days
Intervention: LMWH parnaparin subcutaneously
C
C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days
Intervention: LMWH parnaparin subcutaneously
Outcomes
Primary Outcomes
Primary effectiveness objectives
Time Frame: 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
Time Frame: 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 Outcomes
- Secondary effectiveness objectives(93)
- secondary outcome for safety(33)