Clinical trial NCT00182403: Fixed Dose Heparin Study
Official title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Keywords: Unfractionated Heparin
Low Molecular Weight Heparin
Venous Thromboembolism
APTT
Treatment
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2005-09-16
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Symptomatic Venous Thromboembolism
measure: Major Bleeding
measure: Death
Secondary outcomes:
measure: aXa ~6h after sc injection on 3rd day of treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-General Campus
state: Ontario
city: Hamilton
country: Canada
facility: Hamlton Health Sciences -McMaster Campus
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Henderson Campus
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec City
country: Canada
facility: CHA Pavillon du Saint-Sacrement
state: Quebec
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Otahuhu
country: New Zealand
facility: Middlemore
Study officials:
affiliation: Hamiton Health Sciences
name: Clive Kearon, MB Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster-Dept. of Clinical Epidemiology &Biostatistics
name: Jim Julian, MMath
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/jama.296.8.935.