Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

University of Cincinnati103 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

103

Conditions

Traumatic Injury Venous Thromboembolism

Interventions

Enoxaparin 40 mg q12hDRUG

Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.

Enoxaparin 30 mg q8hDRUG

Patients receive enoxaparin 30 mg every 8 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization

Serum AT-III (% activity) will be compared between the control group and the intervention group patients (combined) after the third dose of enoxaparin 30 mg every 12 hours once initiated at the discretion of the trauma service per current VTE prophylaxis protocol

Time frame: After third dose of enoxaparin 30mg q12h, which will typically be on Day 2 of enoxaparin

Data from ClinicalTrials.gov

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