Overview

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