Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00493896

Enrollment

Registered

2007-06-28

Start date

2007-07-31

Completion date

2010-04-30

Last updated

2022-04-11

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

Conditions

Venous Thromboembolism

Keywords

Venous Thromboembolism Prophylaxis, VTE prophylaxis

Brief summary

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.

Detailed description

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, & platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr \< 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary & secondary diagnoses, central venous access, and sequential compression device utilization.

Interventions

DRUGFondaparinux

The dose for Arixtra is 2.5 mg once daily, subcutaneously.

DRUGEnoxaparin

The dose for Lovenox is 40 mg once daily, subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

1. Ability or legally authorized representative (LAR) to provide informed consent 2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

Exclusion criteria

1. Active or suspected bleeding 2. Platelet count less than 100,000 per microliter (mm3) of blood 3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization 4. Initial estimated CLcr \< 30 ml/min as determined by the Cockcroft-Gault equation 5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (\>1 mg/dL/day) 6. Pregnancy (for medicolegal considerations) 7. Patients with or expecting to require an epidural catheter 8. Patients who are expected to have an immediate (within 24h) need for surgery

Design outcomes

Primary

Measure	Time frame
Bleeding events	inpatient hospitalization

Secondary

Measure	Time frame
Development of thrombocytopenia	inpatient hospitalization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026