Fixed Dose Heparin Study

Pulmonary Embolism Clinical Trial

Official title:

Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182403
• Other study ID #: CTMG-2005-FIDO
• Secondary ID: #NA3640
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 6, 2017
• Start date: September 1998
• Est. completion date: May 2004

Study information

• Verified date: June 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences-General Campus	Hamilton	Ontario
Canada	Hamilton Health Sciences-Henderson Campus	Hamilton	Ontario
Canada	Hamlton Health Sciences -McMaster Campus	Hamilton	Ontario
Canada	St. Joseph's Healthcare Centre	Hamilton	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	CHA Pavillon du Saint-Sacrement	Quebec City	Quebec
New Zealand	Auckland Hospital	Auckland
New Zealand	Middlemore	Otahuhu

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Heart and Stroke Foundation of Ontario

Countries where clinical trial is conducted

Canada,  New Zealand, 

References & Publications (1)

Kearon C, Ginsberg JS, Julian JA, Douketis J, Solymoss S, Ockelford P, Jackson S, Turpie AG, MacKinnon B, Hirsh J, Gent M; Fixed-Dose Heparin (FIDO) Investigators.. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic Venous Thromboembolism
Primary	Major Bleeding
Primary	Death
Secondary	aXa ~6h after sc injection on 3rd day of treatment