Clinical Trial: Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis

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 Summary:

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.


Sponsor: St. Orsola Hospital

Current Primary Outcome:

  • 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.



Original Primary Outcome:

  • Primary effectiveness objectives
  • Combined end-point of symptomatic and asymptomatic DVT, relapse and/or local extension of SVT and symptomatic PE at 30 days.
  • Major bleeding


Current Secondary Outcome:

  • Secondary effectiveness objectives [ Time Frame: 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 [ Time Frame: 33 ]
    the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).


Original Secondary Outcome:

  • Secondary effectiveness objectives
  • 1 – Evaluation of venous thromboembolic events with follow-up 3 months after the start of treatment.
  • 2 – Reduction in local symptoms (subjective and objective evaluation).
  • Safety
  • Composite outcome of: minor haemorrhages, thrombocytopenia or any other adverse event (e.g. local allergic reactions).


Information By: St. Orsola Hospital

Dates:
Date Received: August 11, 2006
Date Started: August 2006
Date Completion:
Last Updated: November 22, 2016
Last Verified: August 2012