Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Complejo Hospitalario Xeral-Calde

Status and phase: Completed; Phase 4

Conditions: Acute Pulmonary Embolism

Treatments: Drug: acenocoumarol; Drug: tinzaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00711308

EX0401ES

eudract-no. 2004-002019-97

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

tinzaparin

Experimental group

Description:

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

Treatment:

Drug: tinzaparin

acenocoumarol

Active Comparator group

Description:

tinzaparin followed by acenocoumarol for 6 months

Treatment:

Drug: tinzaparin

Drug: acenocoumarol