Status:
TERMINATED
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Anticoagulants and Bleeding Disorders
Surgery
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
The main objective of this study is to determine the time interval following the last treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less than 0.2 international...
Detailed Description
Enoxaparin is a factor Xa inhibitor commonly used for both prophylaxis against and treatment of thromboembolism. It is also frequently used off-label as a perioperative bridge for patients that are ch...
Eligibility Criteria
Inclusion
- Eligible patients need:
- to be on treatment dose (1mg/kg twice daily or 1.5mg/kg daily) enoxaparin at the time of presentation for elective surgery
- and must be able to accurately report the timing of their last dose and the administered dosage.
- Patients must also be between the ages of 18-100 years of age
- and must be able to give written consent to participate.
Exclusion
- Patients with severe renal insufficiency (creatinine clearance \<30ml/min) will be excluded from the study, as the elimination of enoxaparin is known to be affected in this patient population.
- Pregnant patients will also be excluded, as the elimination and metabolism of enoxaparin is known to be altered in this patient population, and dose adjustments are recommended if treatment dose enoxaparin is used during pregnancy.
- Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting medication will be excluded as this could unpredictably affect the results of anti-Xa testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03296033
Start Date
October 24 2017
End Date
January 14 2022
Last Update
October 5 2023
Active Locations (1)
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1
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157