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Completed

NCT Number: NCT00711308

Tinzaparin in the Treatment of the Acute Pulmonary Embolism

The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

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Key information

Conditions

Acute Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pneumology Service. Hospital Clínico, Santiago de Compostela, A Coruña, Spain

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About this study

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin) administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis.

To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic pulmonary embolism patients confirmed by:
  • High probability ventilation/perfusion lung scan according to the PIOPED criteria
  • Spiral chest computed tomography, or
  • Pulmonary arteriography
  • Aged 18 years or above, of either sex
  • The patient must provide signed informed consent
  • Patients will be agreed for receiving ambulatory anticoagulant treatment

Exclusion criteria

  • Massive pulmonary embolism
  • Allergy to heparin, other components of Tinzaparin or acenocoumarol
  • Previous thrombocytopenia induced by heparin
  • Thrombocytopenia < 100000/mm3
  • History/signs/symptoms of congenital bleeding disorder
  • Life expectancy less than 90 days
  • Unfractioned heparin anticoagulation for more than 36 hours prior enrollment
  • Inability to participate in the home tinzaparin program
  • Clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis
  • Hemoglobin lower than 7 g/dL or Creatinin > 3mg/dL
  • Cerebral-vascular accident
  • Cerebral, medullary and ophthalmological surgery

Treatment and study plan

tinzaparin

Drug

tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months

Other names: innohep

acenocoumarol

Drug

acenocoumarol for 6 months

Other names: vitamin K antagonist

Primary outcomes

  1. Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin

    Time frame: 6 months

Secondary outcomes

  1. direct and indirect cost of each treatment regimen

    Time frame: 6 months

  2. Major haemorrhagic events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Xeral-Calde

Other

Collaborators

  • LEO Pharma

Registry information

Official study title

Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
Feb 13, 2009

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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