Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities

February 26, 2008 updated by: Aalborg University Hospital

Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.

The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.

As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.

This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

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

  • Denmark
    • Region Nordjylland
      • Aalborg, Region Nordjylland, Denmark, 9000
        • Dept. of Haematology; Aalborg Hospital

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:

  • First DVT with or without known risk factors except overt cancer
  • Second DVT more than two years after the first if the patient was without clinical signs of CVI.

Exclusion Criteria:

  • Contraindication to anticoagulation therapy
  • Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
  • Known cancer at the time of the DVT diagnosis
  • Patients unable to cooperate for anticoagulation therapy or manage the tests.

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
Active Comparator: 1
UFH: patients treated with unfractionated heparin
Drug: unfractionated heparin
UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value
Other Names:
  • Heparin SAD 1000 IU/ml
Experimental: 2
FH: patients treated with low-molecular-weight (fractionated) heparin
Drug: Tinzaparin (Leo)
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
Other Names:
  • Innohep (Leo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Time Frame: Two years and 6 to 10 years
Two years and 6 to 10 years

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Collaborators

Aalborg University

Investigators

  • Principal Investigator: Benedicte Laursen, MD, DMSc, Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

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

October 1, 1993

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2008

Last Update Submitted That Met QC Criteria

February 26, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VN 2003/15 (2-16-4 - 0001- 03)

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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