Fixed Dose Heparin Study

McMaster University

Status and phase

Completed

Phase 3

Conditions

Pulmonary Embolism

Venous Thromboembolism

Deep Vein Thrombosis

Treatments

Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily

Study type

Interventional

Funder types

Other

Identifiers

NCT00182403

CTMG-2005-FIDO

#NA3640

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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