Cincinnati, Ohio 45216


Purpose:

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.


Study summary:

This is a pilot study to determine if AT-III serum concentrations differ between patients with normal (>= 0.1 IU/mL) versus subtherapeutic (<0.1 IU/mL) anti-Xa trough concentrations when placed on enoxaparin 30 mg twice daily for venous thromboembolism (VTE) prophylaxis. Secondarily, this study will compare two enoxaparin dosing strategies: standard 30 mg twice daily and a dosing strategy based on trough anti-Xa values in high-risk trauma patients. Specific aims include: 1) to compare the extent of reduced AT-III activity between patients with trough anti-Xa >= 0.1 IU/mL and < 0.1 IU/mL upon initial assay; 2) to determine the proportion of patients who reach goal anti-Xa and the time to goal anti-Xa achievement between two interventional dosing strategies: enoxaparin 40 mg every 12 hours (with consideration to increase to 50 mg every 12 hours if recheck anti-Xa is not at goal) and enoxaparin 30 mg every eight hours; 3) to compare anti-Xa enoxaparin dosing strategies based on VTE, bleeding rates, transfusion requirements, drug discontinuation rate and bioaccumulation, and 4) to determine patient-specific factors that correlate to subtherapeutic anti-Xa such as serial AT-III activity, weight, body mass index, age, cumulative fluid administration, and thromboelastography (TEG).


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


NCT ID:

NCT02412982


Primary Contact:

Molly Droege, PharmD
Phone: 513-584-2126
Email: Molly.Droege@UCHealth.com


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45216
United States

Molly Droege, PharmD
Phone: 513-584-2126

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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