Tinzaparin in the Treatment of the Acute Pulmonary Embolism

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

Detailed Description
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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.

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

Conditions
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Acute Pulmonary Embolism

Intervention / Treatment
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* Drug: tinzaparin
* Drug: acenocoumarol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tinzaparin<br>tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months | Drug: tinzaparin<br>* tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months<br>* Other names: innohep;|
| Active Comparator: acenocoumarol<br>tinzaparin followed by acenocoumarol for 6 months | Drug: tinzaparin<br>* tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months<br>* Other names: innohep;Drug: acenocoumarol<br>* acenocoumarol for 6 months<br>* Other names: vitamin K antagonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| direct and indirect cost of each treatment regimen |  | 6 months | 
| Major haemorrhagic events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm