Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study.
Eva N HamulyákHanke M G WiegersLuuk J J ScheresBarbara A HuttenMaria E de LangeAnne TimmermansPeter E WesterweelMarten R NijzielMarieke J H A KruipMarije Ten WoldePaula F YpmaFrederikus Albertus KlokLaurens NieuwenhuizenSanne van WissenMarcel M C HovensLaura M FaberPieter W KamphuisenHarry R BüllerSaskia MiddeldorpPublished in: Research and practice in thrombosis and haemostasis (2020)
Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.