Back to resultsFixed Dose Heparin Study
Primary Purpose
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
UFH 250 U/kg or LMWH 100 U/kg sc twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thromboembolism focused on measuring Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, Treatment
Eligibility 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
Sites / Locations
- Hamilton Health Sciences-General Campus
- Hamlton Health Sciences -McMaster Campus
- St. Joseph's Healthcare Centre
- Hamilton Health Sciences-Henderson Campus
- McGill University Health Centre
- CHA Pavillon du Saint-Sacrement
- Auckland Hospital
- Middlemore
Outcomes
Primary Outcome Measures
Symptomatic Venous Thromboembolism
Major Bleeding
Death
Secondary Outcome Measures
aXa ~6h after sc injection on 3rd day of treatment
Full Information
NCT ID
NCT00182403
First Posted
September 13, 2005
Last Updated
June 6, 2017
Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT00182403
Brief Title
Fixed Dose Heparin Study
Official Title
Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
Keywords
Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
866 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
UFH 250 U/kg or LMWH 100 U/kg sc twice daily
Primary Outcome Measure Information:
Title
Symptomatic Venous Thromboembolism
Title
Major Bleeding
Title
Death
Secondary Outcome Measure Information:
Title
aXa ~6h after sc injection on 3rd day of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MB Ph.D
Organizational Affiliation
Hamiton Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, MMath
Organizational Affiliation
McMaster-Dept. of Clinical Epidemiology &Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences-General Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Hamlton Health Sciences -McMaster Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Healthcare Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton Health Sciences-Henderson Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
CHA Pavillon du Saint-Sacrement
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Facility Name
Middlemore
City
Otahuhu
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
16926353
Citation
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. doi: 10.1001/jama.296.8.935.
Results Reference
result
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Fixed Dose Heparin Study
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