Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-02-28

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.

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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.

Conditions

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Acute Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tinzaparin

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

Group Type EXPERIMENTAL

tinzaparin

Intervention Type DRUG

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

acenocoumarol

tinzaparin followed by acenocoumarol for 6 months

Group Type ACTIVE_COMPARATOR

tinzaparin

Intervention Type DRUG

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

acenocoumarol

Intervention Type DRUG

acenocoumarol for 6 months

Interventions

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tinzaparin

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

Intervention Type DRUG

acenocoumarol

acenocoumarol for 6 months

Intervention Type DRUG

Other Intervention Names

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innohep vitamin K antagonist

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No