Fixed Dose Heparin Study - Full Text View

Purpose

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).

Condition	Intervention	Phase
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism	Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily	Phase III

MedlinePlus related topics:

Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for:

Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

Further study details as provided by McMaster University:

Primary Outcome Measures:

Symptomatic Venous Thromboembolism
Major Bleeding
Death

Secondary Outcome Measures:

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

Estimated Enrollment:	866
Study Start Date:	September 1998
Estimated Study Completion Date:	May 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182403

Locations


Canada, Ontario
	Hamilton Health Sciences-Henderson Campus
	Hamilton, Ontario, Canada, L8V 1C3
	Hamlton Health Sciences -McMaster Campus
	Hamilton, Ontario, Canada, L8N 3Z5
	Hamilton Health Sciences-General Campus
	Hamilton, Ontario, Canada, L8L 2X2
	St. Joseph's Healthcare Centre
	Hamilton, Ontario, Canada, L8N 4A6

Canada, Quebec
	McGill University Health Centre
	Montreal, Quebec, Canada, H3G 1A4
	CHA Pavillon du Saint-Sacrement
	Quebec City, Quebec, Canada

New Zealand
	Auckland Hospital
	Auckland, New Zealand
	Middlemore
	Otahuhu, New Zealand

Sponsors and Collaborators

Hamilton Health Sciences

Heart and Stroke Foundation of Ontario

Investigators


Principal Investigator:	Clive Kearon, MB Ph.D	Hamiton Health Sciences

Principal Investigator:	Jim Julian, MMath	McMaster-Dept. of Clinical Epidemiology &Biostatistics

More Information

Publications of Results:

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 heparin for acute treatment of venous thromboembolism. JAMA. 2006 Aug 23;296(8):935-42.

Study ID Numbers:	CTMG-2005-FIDO, #NA3640
First Received:	September 13, 2005
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00182403
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Unfractionated Heparin

Low Molecular Weight Heparin

Venous Thromboembolism

APTT

Treatment

Study placed in the following topic categories:

Pulmonary Embolism

Heparin, Low-Molecular-Weight

Vascular Diseases

Venous Thromboembolism

Thrombosis

Thromboembolism

Calcium heparin

Body Weight

Embolism and Thrombosis

Respiratory Tract Diseases

Embolism

Lung Diseases

Venous Thrombosis

Heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	Hamilton Health Sciences Heart and Stroke Foundation of Ontario
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182403