Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412982
• Other study ID #: Droege2015
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2021
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Traumatic Injury
• Venous Thromboembolism
• Wounds and Injuries

Intervention

Drug:
• Enoxaparin 40 mg q12h
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 q8h
Patients receive enoxaparin 30 mg every 8 hours.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	United States Air Force

Country where clinical trial is conducted

United States, 

References & Publications (1)

Droege ME, Droege CA, Philpott CD, Webb ML, Ernst NE, Athota K, Wakefield D, Dowd JR, Gomaa D, Robinson BHR, Hanseman D, Elterman J, Mueller EW. Impact of antithrombin III and enoxaparin dosage adjustment on prophylactic anti-Xa concentrations in trauma p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After third dose of enoxaparin 30mg q12h, which will typically be on Day 2 of enoxaparin