Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 27
- Primary Endpoint
- Bleeding events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability or legally authorized representative (LAR) to provide informed consent
- •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
- •Active or suspected bleeding
- •Platelet count less than 100,000 per microliter (mm3) of blood
- •Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
- •Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
- •Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
- •Pregnancy (for medicolegal considerations)
- •Patients with or expecting to require an epidural catheter
- •Patients who are expected to have an immediate (within 24h) need for surgery
Arms & Interventions
Fondaparinux
Fondaparinux treatment - one standard of care option
Intervention: Fondaparinux (Drug)
2
Enoxaparin
Intervention: Enoxaparin (Drug)
Outcomes
Primary Outcomes
Bleeding events
Time Frame: inpatient hospitalization
Secondary Outcomes
- Development of thrombocytopenia(inpatient hospitalization)