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Evaluation of Major Bleeding with Dabigatran

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TJ Milling, MD, of the Dell Medical School at University of Texas, discusses his study evaluating the real-world occurrence of major hemorrhages in patients taking dabigatran (Pradaxa). The study looked to define how hemorrhages in patients on dabigatran were being treated, what drugs/doses were being used to reverse the bleeding, and what the outcomes were. Over 500 charts were reviewed, and a database of over 200 major hemorrhage patients was created. The study found that GI bleeds occurred most frequently (80%), ICH occurred in 10% of cases, and less severe bleeding occurred less commonly (i.e. epistaxis, retroperitoneal hemorrhage). Interestingly, out of 36 ICH’s, only 2 deaths were noted, which was lower than expected with either warfarin or dabigatran. For reversal strategies, there were varied approaches noted.

Thomas baldrick here thrombosis tv coverage of the 2015 is th conference in toronto joined now by dr. tj milling from the delhi university of texas medical school thank you sir i know you just got to town thanks for coming by my pleasure thanks for having me let’s talk about this study of yours can you first give us a background on it surely pradaxa the new direct

Thrombin inhibitor blood thinner has been on the market since you know four or five years and the curiosity was well what’s happening in clinical practice with major hemorrhage i think they’d all know from the clinical trials that got the registration with the fda that it was non-inferior to warfarin but outside of a clinical trial we were curious how major hemorrhage

Is on pradaxa were being treated how clinicians were attempting to reverse the blood thinner and in cases of life-threatening hemorrhage and what some of the outcomes were and what is the data that you have to present sure so we reviewed over 500 charts at in five cities and multiple hospitals and together a database of over 200 major hemorrhage patients as you’d

Expect about eighty percent of those or gi bleeds upper and lower gi bleeds ten percent or so or our interest cerebral hemorrhages intracranial hemorrhages and then there’s this mattering of you know epistaxis retroperitoneal hemorrhage and that sort of thing it was a little surprising that the intracranial hemorrhage is given this you know all the limitations of

A retrospective chart review kind of study out of 36 i see h’s this is including both traumatic and spontaneous only two deaths which is much lower than you would expect with warfarin or pradaxa what does this day to say to you well the most as an emergency physician the most interesting part for me was looking at what people were using to reverse the so-called

Irreversible anticoagulants and that’s a major criticism of all the no acts right so the reversal agents are for the factor of 10 a inhibitors like rivaroxaban in a pic seban and the dti pradaxa are all in late phase clinical trials and the reversal agent for pradaxa may be available very soon but for the last four years clinicians have kind of been left on their

Own to figure out what to do when a patient’s bleeding to death in front of you and they’re on this sanic coagulant so that to me was the most interesting thing and it was given the uncertainty of what to do there was a wide variety of what was done dr. milling what would you say physicians should do with this research so i i think it informs us a little bit about

The maybe the perception of helplessness of clinicians in the face of major hemorrhage on these drugs and very little guidance i still think the agents we probably should use until we have a specific reversal agent or pccs and you know both activated and non-activated pccs and patients tend to do pretty well despite a sort of varied approach to treating in this in

These scenarios thank you for coming by we appreciate it my pleasure thanks for having me

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Evaluation of Major Bleeding with Dabigatran By Thrombosis.TV