Fixed Dose Heparin Study

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182403
First received: September 13, 2005
Last updated: November 29, 2006
Last verified: September 2005

September 13, 2005
November 29, 2006
September 1998
Not Provided
  • Symptomatic Venous Thromboembolism
  • Major Bleeding
  • Death
Same as current
Complete list of historical versions of study NCT00182403 on ClinicalTrials.gov 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
866
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   New Zealand
 
NCT00182403
CTMG-2005-FIDO, #NA3640
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Principal Investigator: Clive Kearon, MB Ph.D Hamiton Health Sciences
Principal Investigator: Jim Julian, MMath McMaster-Dept. of Clinical Epidemiology &Biostatistics
McMaster University
September 2005

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