NCT00182403

Fixed Dose Heparin Study

Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 866 (planned)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	UFH 250 U/kg or LMWH 100 U/kg sc twice daily

Timeline

• Start date: 1998-09-01
• Completion: 2004-05-01
• First posted: 2005-09-16
• Last updated: 2017-06-07

Locations

8 sites across 2 countries: Canada, New Zealand