Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493896
• Other study ID #: 107696
• Status: Terminated
• Phase: Phase 3
• Start date: July 2007
• Est. completion date: April 2010

Study information

• Verified date: April 2022
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux
The dose for Arixtra is 2.5 mg once daily, subcutaneously.
• Enoxaparin
The dose for Lovenox is 40 mg once daily, subcutaneously.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding events		inpatient hospitalization
Secondary	Development of thrombocytopenia		inpatient hospitalization