Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Phase 4

Completed

• Conditions: Acute Pulmonary Embolism
• Interventions: Drug: tinzaparin; Drug: acenocoumarol

• Registration Number: NCT00711308
• Lead Sponsor: Complejo Hospitalario Xeral-Calde

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-08
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acenocoumarol	acenocoumarol	tinzaparin followed by acenocoumarol for 6 months
tinzaparin	tinzaparin	tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
acenocoumarol	tinzaparin	tinzaparin followed by acenocoumarol for 6 months

Primary Outcome Measures

Name	Time	Method
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin	6 months

Secondary Outcome Measures

Name	Time	Method
direct and indirect cost of each treatment regimen	6 months
Major haemorrhagic events	6 months

Trial Locations

Locations (4)

Pneumology Service. Hospital do Meixoeiro; 🇪🇸 Vigo, Pontevedra, Spain

Pneumology Service. Hospital Clínico; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Pneumology Service. Hospital Xeral Cies; 🇪🇸 Vigo, Pontevedra, Spain

Pneumology Service; 🇪🇸 Lugo, Spain