Recent (previous seven days), or complicated lumbar puncture or epidural catheter placement or removal.Patient has hepatic disease (including Child-Pugh B and C) associated with coagulopathy or clinically relevant bleeding risk.Patient has severe renal insufficiency (CrCl As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Because this list of these agents are constantly changing, it is important to regularly consult a frequently-updated list. Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P-450 3A4 or p-glycoprotein are ineligible.Patient has a contraindication to apixaban.Patient has hereditary or acquired coagulopathy or bleeding disorder.Patient has signs of active or ongoing clinically significant hemorrhage.treatment with aspirin at a dose of more than 162 mg daily.anticoagulation for another indication for long-term anticoagulation therapy,.Patient requires anticoagulation for a mechanical heart valve.Ability to understand and the willingness to sign a written informed consent document.Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study entry, for the duration of the study participation, and 4 months after completion of apixaban administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control abstinence) prior to study entry and for the duration of study participation. The effects of apixaban on the developing human fetus are unknown.creatinine clearance ≥25 mL/min as was used in the AMPLIFY trial16.AST(SGOT) and ALT(SGPT) ≤2.5 × institutional upper limit of normal.Participants must have organ and marrow function as defined below: ECOG performance status ≤2 (Karnofsky ≥60%).
Antidote for heparin sodium skin#
Progressive or recurrent thrombosis, non-necrotizing (erythematous) skin lesions, or suspected thrombosis that has not been proven - 1 point.Confirmed new thrombosis, skin necrosis, or acute systemic reaction after intravenous unfractionated heparin bolus - 2 points.Platelet count fall at Consistent with fall at 5 to 10 days but unclear (eg, missing platelet counts), onset after day 10, or fall ≤1 day with prior heparin exposure within 30 to 100 days - 1 point.Clear onset between days 5 and 10 or platelet count fall at ≤1 day if prior heparin exposure within the last 30 days - 2 points.Platelet count fall Platelet count fall 30 to 50 percent or nadir 10 to 19,000/microL - 1 points.Platelet count fall >50 percent and nadir ≥20,000/microL - 2 points.Patient must have a diagnosis of HIT or high clinical suspicion of HIT, with a 4 T score of ≥ 5 as calculated by the following criteria:.Hospitalized patients at MGH and participating Dana Farber/Harvard Cancer Center (DF/HCC) sites.The oral route of apixaban allows for the potential outpatient treatment of HIT or HITT which is both convenient and less expensive than treatment with argatroban. The investigators believe that apixaban will work just as well as argatroban and will be more convenient for this population. In this research study, the investigators are researching the activity and tolerability of apixaban in participants with HIT or HITT. As of now the only drug that is FDA approved for HIT or HITT is argatroban, which is administered continuously through an IV over multiple days and is extremely costly. Once patients are diagnosed with either one of these, they are typically switched to a non-heparin anticoagulant (a type of drug that thins your blood). HIT and HITT are common and severe complications of heparin therapy.
Food and Drug Administration) has not approved apixaban as a treatment option for this specific disease but it has been approved for other uses. This research study is a Phase II clinical trial.
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