Fixed Dose Heparin Study

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation; McMaster University
• Collaborators: Heart and Stroke Foundation of Canada; Heart and Stroke Foundation of Ontario
• Treatments: Calcium heparin; Heparin

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