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Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Primary Purpose

Acute Pulmonary Embolism

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
tinzaparin
acenocoumarol
Sponsored by
Complejo Hospitalario Xeral-Calde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pulmonary Embolism focused on measuring pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pneumology Service. Hospital Clínico
  • Pneumology Service. Hospital Xeral Cies
  • Pneumology Service. Hospital do Meixoeiro
  • Pneumology Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tinzaparin

acenocoumarol

Arm Description

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

tinzaparin followed by acenocoumarol for 6 months

Outcomes

Primary Outcome Measures

Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin

Secondary Outcome Measures

direct and indirect cost of each treatment regimen
Major haemorrhagic events

Full Information

First Posted
July 3, 2008
Last Updated
February 12, 2009
Sponsor
Complejo Hospitalario Xeral-Calde
Collaborators
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00711308
Brief Title
Tinzaparin in the Treatment of the Acute Pulmonary Embolism
Official Title
Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Complejo Hospitalario Xeral-Calde
Collaborators
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulmonary Embolism
Keywords
pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tinzaparin
Arm Type
Experimental
Arm Description
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Arm Title
acenocoumarol
Arm Type
Active Comparator
Arm Description
tinzaparin followed by acenocoumarol for 6 months
Intervention Type
Drug
Intervention Name(s)
tinzaparin
Other Intervention Name(s)
innohep
Intervention Description
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
acenocoumarol
Other Intervention Name(s)
vitamin K antagonist
Intervention Description
acenocoumarol for 6 months
Primary Outcome Measure Information:
Title
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
direct and indirect cost of each treatment regimen
Time Frame
6 months
Title
Major haemorrhagic events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Pérez de Llano, MD
Organizational Affiliation
Complejo Hospitalario Xeral Calde (Lugo)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alejandro Veres Racamonde, MD
Organizational Affiliation
Complejo Hospitalario Xeral Calde (Lugo)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Núnez Delgado, MD
Organizational Affiliation
Hospital do Meixoeiro (Vigo)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Palacios Bartolomé, MD
Organizational Affiliation
Hospital Clínico de Santiago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginia Leiro Fernández, MD
Organizational Affiliation
Hospital Xeral (Vigo)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pneumology Service. Hospital Clínico
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pneumology Service. Hospital Xeral Cies
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Pneumology Service. Hospital do Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36214
Country
Spain
Facility Name
Pneumology Service
City
Lugo
ZIP/Postal Code
27004
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Tinzaparin in the Treatment of the Acute Pulmonary Embolism

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