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Fixed Dose Heparin Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182403
First Posted: September 16, 2005
Last Update Posted: June 7, 2017
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.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University
  Purpose
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 Intervention Phase
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Symptomatic Venous Thromboembolism
  • Major Bleeding
  • Death

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

Estimated Enrollment: 866
Study Start Date: September 1998
Estimated Study Completion Date: May 2004
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00182403


Locations
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
Middlemore
Otahuhu, New Zealand
Sponsors and Collaborators
McMaster University
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00182403     History of Changes
Other Study ID Numbers: CTMG-2005-FIDO
#NA3640
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: June 7, 2017
Last Verified: June 2017

Keywords provided by McMaster University:
Unfractionated Heparin
Low Molecular Weight Heparin
Venous Thromboembolism
APTT
Treatment

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action