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Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Injury; Venous Thromboembolism

Intervention: Enoxaparin 40 mg q12h (Drug); Enoxaparin 30 mg q8h (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Cincinnati

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

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.

Clinical Details

Official title: Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients: A Prospective Randomized Trial of Standard Enoxaparin Versus Two Anti-Xa Adjusted Dosing Strategies

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Initial AT-III activity -- control group vs. other two groups combined

Secondary outcome: Goal anti-Xa attainment / first repeat assessment

Detailed description: 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).

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: June 2015
Last updated: April 6, 2015

Page last updated: August 20, 2015

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