Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants 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.

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.

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