Fixed Dose Heparin Study

June 6, 2017 updated by: McMaster University

Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.

Study Type

Interventional

Enrollment

866

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences-General Campus
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamlton Health Sciences -McMaster Campus
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Centre
      • Hamilton, Ontario, Canada, L8V 1C3
        • Hamilton Health Sciences-Henderson Campus
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
      • Quebec City, Quebec, Canada
        • CHA Pavillon du Saint-Sacrement
  • New Zealand
      • Auckland, New Zealand
        • Auckland Hospital
      • Otahuhu, New Zealand
        • Middlemore

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:

  • A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)

Exclusion Criteria:

  • Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours)
  • Active Bleeding process
  • Comorbid condition limiting expected survival to less than 3 months
  • Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours
  • Currently on long term warfarin or heparin therapy
  • Allergy to heparin or history of heparin induced thrombocytopenia
  • Currently pregnant
  • Contraindication to contrast media (eg: allergy or creatinine >200 umol/L).
  • Currently enrolled or will be enrolled in a competing study
  • Geographically inaccessible for follow-up assessment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death
Symptomatic Venous Thromboembolism
Major Bleeding

Secondary Outcome Measures

Outcome Measure
aXa ~6h after sc injection on 3rd day of treatment

Collaborators and Investigators

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

Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Clive Kearon, MB Ph.D, Hamiton Health Sciences
  • Principal Investigator: Jim Julian, MMath, McMaster-Dept. of Clinical Epidemiology &Biostatistics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 1998

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-2005-FIDO
  • #NA3640

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.

Subscribe