Fixed Dose Heparin Study
Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
2 other identifiers
interventional
866
2 countries
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 1998
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedJune 7, 2017
June 1, 2017
September 13, 2005
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Symptomatic Venous Thromboembolism
Major Bleeding
Death
Secondary Outcomes (1)
aXa ~6h after sc injection on 3rd day of treatment
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (8)
Hamilton Health Sciences-General Campus
Hamilton, Ontario, L8L 2X2, Canada
Hamlton Health Sciences -McMaster Campus
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Healthcare Centre
Hamilton, Ontario, L8N 4A6, Canada
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, L8V 1C3, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
CHA Pavillon du Saint-Sacrement
Québec, Quebec, Canada
Auckland Hospital
Auckland, New Zealand
Middlemore
Otahuhu, New Zealand
Related Publications (1)
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.
PMID: 16926353RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clive Kearon, MB Ph.D
Hamiton Health Sciences
- PRINCIPAL INVESTIGATOR
Jim Julian, MMath
McMaster-Dept. of Clinical Epidemiology &Biostatistics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
September 1, 1998
Study Completion
May 1, 2004
Last Updated
June 7, 2017
Record last verified: 2017-06