Fixed Dose Heparin Study

Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182403

Enrollment

866

Registered

2005-09-16

Start date

1998-09-30

Completion date

2004-05-31

Last updated

2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Keywords

Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, 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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Symptomatic Venous Thromboembolism	—
Major Bleeding	—
Death	—

Secondary

Measure	Time frame
aXa ~6h after sc injection on 3rd day of treatment	—

Countries

Canada, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026