Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis|
- Primary effectiveness objectives [ Time Frame: 33 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
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 effectiveness objectives [ Time Frame: 93 ] [ Designated as safety issue: No ]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 [ Time Frame: 33 ] [ Designated as safety issue: Yes ]the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).
|Study Start Date:||August 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: A
A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days
Active Comparator: 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
|Drug: LMWH parnaparin subcutaneously|
Active Comparator: C
C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days
|Drug: LMWH parnaparin subcutaneously|
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.
|Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi|
|Bologna, BO, Italy, 40138|
|U.O. Medicina Critica|
|Piacenza, PC, Italy, 29100|
|Study Chair:||Gualtiero Palareti, MD||University of Bologna|
|Principal Investigator:||Benilde Cosmi, MD PhD||University of Bologna|