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

September 13, 2005
September 16, 2005
June 7, 2017
September 1998
Not Provided
  • Symptomatic Venous Thromboembolism
  • Major Bleeding
  • Death
Same as current
Complete list of historical versions of study NCT00182403 on Archive Site
aXa ~6h after sc injection on 3rd day of treatment
Same as current
Not Provided
Not Provided
Fixed Dose Heparin Study
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).
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily
Not Provided
Kearon C, Ginsberg JS, Julian JA, Douketis J, Solymoss S, Ockelford P, Jackson S, Turpie AG, MacKinnon B, Hirsh J, Gent M; Fixed-Dose Heparin (FIDO) Investigators. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-42.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   New Zealand
Not Provided
Not Provided
Not Provided
Not Provided
McMaster University
Heart and Stroke Foundation of Ontario
Principal Investigator: Clive Kearon, MB Ph.D Hamiton Health Sciences
Principal Investigator: Jim Julian, MMath McMaster-Dept. of Clinical Epidemiology &Biostatistics
McMaster University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP