Venous ThromboembolismPhase 3NCT00182403
Fixed Dose Heparin Study
A Phase 3 study testing UFH 250 U/kg or LMWH 100 U/kg sc twice daily in people with Venous Thromboembolism and Deep Vein Thrombosis, run by McMaster University at 8 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- UFH 250 U/kg or LMWH 100 U/kg sc twice daily
- How many people
- 866 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 1998to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada6 sites
Hamilton Health Sciences-General Campus
Hamilton, Ontario, L8L 2X2
Hamlton Health Sciences -McMaster Campus
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare Centre
Hamilton, Ontario, L8N 4A6
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, L8V 1C3
McGill University Health Centre
Montreal, Quebec, H3G 1A4
CHA Pavillon du Saint-Sacrement
Québec, Quebec
About this study
Official title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
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).
Read the 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.
- Being tested
- UFH 250 U/kg or LMWH 100 U/kg sc twice daily
- Keywords
- Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, Treatment
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFH 250 U/kg or LMWH 100 U/kg sc twice dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Venous Thromboembolism
Major Bleeding
Death
Secondary outcomes (1)
aXa ~6h after sc injection on 3rd day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 1998
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 866 participants
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Clive Kearon, MB Ph.D, Principal investigator, Hamiton Health SciencesJim Julian, MMath, Principal investigator, McMaster-Dept. of Clinical Epidemiology &Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182403
- Sponsor's protocol ID
- CTMG-2005-FIDO
- Other IDs
- #NA3640
- Status last verified
- Jun 2017
- First submitted
- 13 Sep 2005
- Last updated
- 7 Jun 2017
- Results posted
- No
Publications
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.
PubMed 16926353
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT00182403
- Acronym / sponsor ID
- CTMG-2005-FIDO
- Keywords
- Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Sep 1998
- Study completion
- May 2004
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UFH 250 U/kg or LMWH 100 U/kg sc twice daily | Drug | – |
Primary outcome
Symptomatic Venous Thromboembolism
Major Bleeding
Death
1 secondary outcome
aXa ~6h after sc injection on 3rd day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Results publication: PubMed 16926353Kearon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clive Kearon, MB Ph.D principal investigator
Hamiton Health Sciences
Jim Julian, MMath principal investigator
McMaster-Dept. of Clinical Epidemiology &Biostatistics
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UFH 250 U/kg or LMWH 100 U/kg sc twice daily in people with Venous Thromboembolism and Deep Vein Thrombosis, run by McMaster University at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic Venous Thromboembolism. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.