Acute Pulmonary Embolism
Conditions
Keywords
pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm
Brief 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.
Detailed description
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.
Interventions
DRUGtinzaparin
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
DRUGacenocoumarol
acenocoumarol for 6 months
Sponsors
LEO Pharma
Complejo Hospitalario Xeral-Calde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| direct and indirect cost of each treatment regimen | 6 months |
| Major haemorrhagic events | 6 months |
Countries
Spain
Outcome results
None listed