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Fixed Dose Heparin Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182403
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 7, 2017
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 866 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Study Start Date : September 1998
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin

Primary Outcome Measures :
  1. Symptomatic Venous Thromboembolism
  2. Major Bleeding
  3. Death

Secondary Outcome Measures :
  1. aXa ~6h after sc injection on 3rd day of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182403

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Canada, Ontario
Hamilton Health Sciences-General Campus
Hamilton, Ontario, Canada, L8L 2X2
Hamlton Health Sciences -McMaster Campus
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V 1C3
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
CHA Pavillon du Saint-Sacrement
Quebec City, Quebec, Canada
New Zealand
Auckland Hospital
Auckland, New Zealand
Otahuhu, New Zealand
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
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Principal Investigator: Clive Kearon, MB Ph.D Hamiton Health Sciences
Principal Investigator: Jim Julian, MMath McMaster-Dept. of Clinical Epidemiology &Biostatistics
Publications of Results:
Layout table for additonal information Identifier: NCT00182403    
Other Study ID Numbers: CTMG-2005-FIDO
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Keywords provided by McMaster University:
Unfractionated Heparin
Low Molecular Weight Heparin
Venous Thromboembolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases