11/21/2023 0 Comments Annexa 4 trialIf a patient meets any of the following criteria, he or she is not eligible: Willingness to use highly effective methods of contraception through 30 days following study drug dose (for female and male patients who are fertile).Have a negative pregnancy test documented prior to enrollment (for women of childbearing potential).Note: Patients enrolled in this manner should receive a high-andexanet dosing regimen. Age ≥ 18 and 15 hours prior to start of surgery or unknown time from the last dose, if documented anti fXa activity is > 100 ng/mL (> 0.5 IU/mL for enoxaparin, or over the equivalent IU/mL threshold on a low molecular weight heparin assay see Laboratory Manual) within 2 hours prior to consent.Either the patient or their medical proxy (or legal designee) has given written informed consent.Why Should I Register and Submit Results?Īll of the following criteria must be met for the patient to be eligible:.
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