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Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
tinzaparin
acenocoumarol
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Venous thromboembolism, low molecular weight heparin, Vitamin K antagonist, Longterm

Eligibility Criteria

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

Inclusion Criteria:

  • Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
  • either sex and over 18 years of age
  • referred to the Vascular Surgery Department of the hospital
  • onset of symptoms less than 2 weeks
  • documented by compression ultrasonography,

Exclusion Criteria:

  • received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
  • pulmonary embolism requiring thrombolytic therapy
  • Need of surgical thrombectomy or vena cava interruption
  • receiving oral anticoagulant treatment or antiplatelet agents for other conditions
  • contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
  • platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
  • severe renal failure necessitating dialysis
  • pregnancy
  • lumbar puncture within the previous 24 hours

Sites / Locations

  • Vascular surgery service. Hospital Creu Roja de l'Hospitalet
  • Department of Vascular Surgery. Hospital Universitari de Bellvitge

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 for 1 weeks followed by acenocoumarol for 6 months

Outcomes

Primary Outcome Measures

Incidence of symptomatic recurrent venous thromboembolism

Secondary Outcome Measures

Occurrence of major bleeding

Full Information

First Posted
May 28, 2008
Last Updated
June 2, 2008
Sponsor
Hospital Universitari de Bellvitge
Collaborators
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00689520
Brief Title
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
Official Title
Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
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 a similar period of time in patients with proximal venous thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Venous thromboembolism, 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
241 (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 for 1 weeks 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 antagonists
Intervention Description
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
Primary Outcome Measure Information:
Title
Incidence of symptomatic recurrent venous thromboembolism
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Occurrence of major bleeding
Time Frame
6 month treatment interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs. either sex and over 18 years of age referred to the Vascular Surgery Department of the hospital onset of symptoms less than 2 weeks documented by compression ultrasonography, Exclusion Criteria: received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease pulmonary embolism requiring thrombolytic therapy Need of surgical thrombectomy or vena cava interruption receiving oral anticoagulant treatment or antiplatelet agents for other conditions contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs) platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia severe renal failure necessitating dialysis pregnancy lumbar puncture within the previous 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Romera, MD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antoni Romera, MD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oriol Lapiedra, MD
Organizational Affiliation
Hospital Creu Roja de l'Hospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular surgery service. Hospital Creu Roja de l'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Department of Vascular Surgery. Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

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Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

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