Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00182403




Registration number
NCT00182403
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
7/06/2017

Titles & IDs
Public title
Fixed Dose Heparin Study
Scientific title
Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Secondary ID [1] 0 0
#NA3640
Secondary ID [2] 0 0
CTMG-2005-FIDO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Deep Vein Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UFH 250 U/kg or LMWH 100 U/kg sc twice daily

Treatment: Drugs: UFH 250 U/kg or LMWH 100 U/kg sc twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptomatic Venous Thromboembolism
Timepoint [1] 0 0
Primary outcome [2] 0 0
Major Bleeding
Timepoint [2] 0 0
Primary outcome [3] 0 0
Death
Timepoint [3] 0 0
Secondary outcome [1] 0 0
aXa ~6h after sc injection on 3rd day of treatment
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Otahuhu

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Heart and Stroke Foundation of Ontario
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00182403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clive Kearon, MB Ph.D
Address 0 0
Hamiton Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries