Tinzaparin in the Treatment of the Acute Pulmonary Embolism

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Complejo Hospitalario Xeral-Calde
• Collaborator: LEO Pharma
• Treatments: Acenocoumarol; Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin; Vitamin K; Vitamins

Criteria

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