Overview

Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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 0.2IU/mL in patients presenting for elective surgery.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University Health Sciences
Treatments:
Dalteparin
Enoxaparin
Enoxaparin sodium
Heparin, Low-Molecular-Weight
Criteria
Inclusion Criteria:

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 Criteria:

- 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.