Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

NCT ID: NCT00493896

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-04-30

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Fondaparinux

Fondaparinux treatment - one standard of care option

Group Type: EXPERIMENTAL

Fondaparinux

Intervention Type: DRUG

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

2

Enoxaparin

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

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

Interventions

Fondaparinux

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

Intervention Type: DRUG

Enoxaparin

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

Intervention Type: DRUG

Other Intervention Names

Arixtra; Lovenox

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles W Callender, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern VA Medical School, Norfolk, VA

Other Identifiers

107696

Identifier Type: -

Identifier Source: org_study_id