Fixed Dose Heparin Study

Phase 3

Completed

• Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

• Registration Number: NCT00182403
• Lead Sponsor: McMaster University

Brief 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.

Study Timeline

• Study Start: 1998-09
• Study Completion: 2004-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 866

Inclusion Criteria

• A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptomatic Venous Thromboembolism
Major Bleeding
Death

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Hamilton Health Sciences-General Campus; 🇨🇦 Hamilton, Ontario, Canada

Auckland Hospital; 🇳🇿 Auckland, New Zealand

Hamilton Health Sciences-Henderson Campus; 🇨🇦 Hamilton, Ontario, Canada

Middlemore; 🇳🇿 Otahuhu, New Zealand

St. Joseph's Healthcare Centre; 🇨🇦 Hamilton, Ontario, Canada

Hamlton Health Sciences -McMaster Campus; 🇨🇦 Hamilton, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

CHA Pavillon du Saint-Sacrement; 🇨🇦 Quebec City, Quebec, Canada