Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
1 other identifier
interventional
103
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
October 25, 2021
CompletedOctober 25, 2021
October 1, 2021
2.8 years
February 24, 2015
June 30, 2021
October 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Serum anti-Xa >= 0.1 IU/mL
NO INTERVENTIONPatients with serum anti-Xa level \>= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
Anti-Xa <0.1 IU/mL:enoxaparin 40 mg q12h
ACTIVE COMPARATORPatients with serum anti-Xa level \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours who then receive enoxaparin 40 mg every 12 hours. If repeat steady state trough anti-Xa is subtherapeutic, dose will be increased to enoxaparin 50 mg every 12 hours.
Anti-Xa <0.1 IU/mL:enoxaparin 30 mg q8h
ACTIVE COMPARATORPatients with serum anti-Xa level \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours who then receive enoxaparin 30 mg every eight hours
Serum anti-Xa < 0.1 IU/mL
NO INTERVENTIONPatients with serum anti-Xa level \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
Interventions
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.
Patients receive enoxaparin 30 mg every 8 hours.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- United States Air Forcecollaborator
Study Sites (1)
University of Cincinnati Medical Center
Cincinnati, Ohio, 45216, United States
Related 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 patients at high risk for venous thromboembolism: a randomized pilot trial. J Thromb Thrombolysis. 2021 Nov;52(4):1117-1128. doi: 10.1007/s11239-021-02478-4. Epub 2021 May 12.
PMID: 33978907RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Underpowered; See full results and manuscript listed in citation section.
Results Point of Contact
- Title
- Molly Droege, PharmD
- Organization
- UC Health - University of Cincinnati Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Molly Droege, PharmD
UC Health - University of Cincinnati Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacy Specialist, Trauma, Surgery, and Orthopedics
Study Record Dates
First Submitted
February 24, 2015
First Posted
April 9, 2015
Study Start
March 1, 2016
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
October 25, 2021
Results First Posted
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share