Status:
COMPLETED
Tinzaparin in the Treatment of the Acute Pulmonary Embolism
Lead Sponsor:
Complejo Hospitalario Xeral-Calde
Collaborating Sponsors:
LEO Pharma
Conditions:
Acute Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00711308
Start Date
April 1 2005
End Date
February 1 2009
Last Update
February 13 2009
Active Locations (4)
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1
Pneumology Service. Hospital Clínico
Santiago de Compostela, A Coruña, Spain, 15706
2
Pneumology Service
Lugo, Lugo, Spain, 27004
3
Pneumology Service. Hospital Xeral Cies
Vigo, Pontevedra, Spain, 36204
4
Pneumology Service. Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36214