Tinzaparin in the Treatment of the Acute Pulmonary Embolism

February 12, 2009 updated by: Complejo Hospitalario Xeral-Calde

Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lugo, Spain, 27004
        • Pneumology Service
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Pneumology Service. Hospital Clínico
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Pneumology Service. Hospital Xeral Cies
      • Vigo, Pontevedra, Spain, 36214
        • Pneumology Service. Hospital do Meixoeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tinzaparin
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Drug: tinzaparin
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Other Names:
  • innohep
Active Comparator: acenocoumarol
tinzaparin followed by acenocoumarol for 6 months
Drug: tinzaparin
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Other Names:
  • innohep
Drug: acenocoumarol
acenocoumarol for 6 months
Other Names:
  • vitamin K antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
direct and indirect cost of each treatment regimen
Time Frame: 6 months
6 months
Major haemorrhagic events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complejo Hospitalario Xeral-Calde

Collaborators

LEO Pharma

Investigators

  • Study Chair: Luis Pérez de Llano, MD, Complejo Hospitalario Xeral Calde (Lugo)
  • Principal Investigator: Alejandro Veres Racamonde, MD, Complejo Hospitalario Xeral Calde (Lugo)
  • Principal Investigator: Manuel Núnez Delgado, MD, Hospital do Meixoeiro (Vigo)
  • Principal Investigator: Ana Palacios Bartolomé, MD, Hospital Clínico de Santiago
  • Principal Investigator: Virginia Leiro Fernández, MD, Hospital Xeral (Vigo)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX0401ES
  • eudract-no. 2004-002019-97

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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