Status:
COMPLETED
Fixed Dose Heparin Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Venous Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 warf...
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 unfracti...
Eligibility Criteria
Inclusion
- A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
866 Patients enrolled
Trial Details
Trial ID
NCT00182403
Start Date
September 1 1998
End Date
May 1 2004
Last Update
June 7 2017
Active Locations (8)
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1
Hamilton Health Sciences-General Campus
Hamilton, Ontario, Canada, L8L 2X2
2
Hamlton Health Sciences -McMaster Campus
Hamilton, Ontario, Canada, L8N 3Z5
3
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada, L8N 4A6
4
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V 1C3