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NCT Number: NCT00362947

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.

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Key information

Conditions

Thrombophlebitis Cardiovascular Diseases Embolism and Thrombosis Peripheral Vascular Diseases Phlebitis Thrombosis Vascular Diseases Vasculitis Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi, Bologna, BO, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMWH parnaparin subcutaneously

Drug

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. secondary outcome for safety

    Time frame: 33

    the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Aug 15, 2006
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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