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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182403

Locations
Canada, Ontario
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V 1C3
Hamlton Health Sciences -McMaster Campus
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences-General Campus
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada, L8N 4A6
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
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
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
Study First Received: September 13, 2005
Last Updated: November 29, 2006
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013