Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: GlaxoSmithKline
• Treatments: Enoxaparin; Fondaparinux; PENTA

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