Fixed Dose Heparin Study

McMaster University866 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

866

Conditions

Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

Interventions

UFH 250 U/kg or LMWH 100 U/kg sc twice dailyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Hamilton Health Sciences-General Campus

Hamilton, Ontario, Canada

Hamlton Health Sciences -McMaster Campus

Hamilton, Ontario, Canada

St. Joseph's Healthcare Centre

Hamilton, Ontario, Canada

Hamilton Health Sciences-Henderson Campus

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Symptomatic Venous Thromboembolism

Major Bleeding

Death

Secondary Outcomes

aXa ~6h after sc injection on 3rd day of treatment

Data from ClinicalTrials.gov

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