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Annexa 4 trial10/8/2023 For participants with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.Participant received or was believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban, or enoxaparin.If bleeding was intracranial or intraspinal, the participant must have undergone a head computed tomography (CT) or magnetic resonance imaging (MRI) scan demonstrating the bleeding.Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial.Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin was available, or.Acute bleeding associated with a fall in hemoglobin level by ≥2 grams/deciliter (g/dL), or.Acute bleeding that was potentially life-threatening, or.Why Should I Register and Submit Results?Īcute major bleeding episode that required urgent reversal of anticoagulation defined by at least one of the following:.
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