Fixed Dose Heparin Study | NCT00182403

Studies
Fixed Dose Heparin Study

NCT00182403

Sponsor

McMaster University

Status

Completed

Last Update Posted

Jun 7, 2017Actual

Enrollment

866

Phase

Phase 3

Conditions

Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism

Interventions

UFH 250 U/kg or LMWH 100 U/kg sc twice daily

Countries

Canada
New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
#NA3640

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1998

Primary Completion Date

Not provided

Completion Date

May 2004

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2017

Last Update Posted Date

Jun 7, 2017Actual

Name	Class
Heart and Stroke Foundation of Ontario	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

866

Name	Type	Description	Arm Group Labels	Other Names
UFH 250 U/kg or LMWH 100 U/kg sc twice daily	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptomatic Venous Thromboembolism
Major Bleeding
Death

Secondary Outcomes

Measure	Description	Time Frame
aXa ~6h after sc injection on 3rd day of treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clive Kearon, MB Ph.D	Hamiton Health Sciences	Principal Investigator
Jim Julian, MMath	McMaster-Dept. of Clinical Epidemiology &Biostatistics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences-General Campus		Hamilton	Ontario	L8L 2X2	Canada
Hamlton Health Sciences -McMaster Campus

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16926353	Result	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.

ID	Term
D054556	Venous Thromboembolism
D020246	Venous Thrombosis
D011655	Pulmonary Embolism

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates