Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two enoxaparin dosing strategies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: United States Air Force
• Treatments: Dalteparin; Enoxaparin; Enoxaparin sodium; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Multi-system trauma

• Anticipated length of stay of at least 72 hours

• At high risk (risk adjustment profile [RAP] >= 5) and initiated on enoxaparin 30 mg every 12 hours per VTE prophylaxis protocol

• No counterindication to trauma team VTE prophylaxis protocol (e.g., intracranial bleeding, incomplete spinal cord injury with hematoma within 24 hours post injury, ongoing hemorrhage, uncorrected coagulopathy, >= grade IV liver or spleen injury, intraocular injury)

Exclusion Criteria:

• Renal dysfunction (creatinine clearance < 30 mL/min or on continuous renal replacement therapy)

• Weight < 50 kg or > 150 kg

• Platelet count < 50,000

• Allergy to heparin or low molecular weight heparin

• On therapeutic anticoagulation on admission or requiring it within 24 hours of admission

• Isolated intracranial hemorrhage

• Known hyperbilirubinemia (serum bilirubin > 6.6 mg/dL)

• Pregnancy

• Incarceration