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CME / ABIM MOC

Addressing Trauma Team Challenges in Bleeding Management and Reversal: Your Questions Answered

  • Authors: Noelle N. Saillant, MD; Natalie Kreitzer, MD, MS
  • CME / ABIM MOC Released: 9/13/2022
  • Valid for credit through: 9/13/2023
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  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for cardiologists, emergency medicine physicians, and gastroenterologists.

The goal of this activity is that learners will be better able to understand the role of direct oral anticoagulant (DOAC)-specific reversal agents in the management of major DOAC-related bleeding.

Upon completion of this activity, participants will:

  • Have greater competence related to
    • Timely use of reversal agents to manage major DOAC-associated bleeding for appropriate patients


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Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.


Faculty

  • Noelle N. Saillant, MD

    Assistant Professor of Surgery
    Boston University School of Medicine
    Surgeon/Surgical Intensivist
    Boston Medical Center
    Department of Acute Care & Trauma Surgery
    Boston, Massachusetts

    Disclosures

    Noelle N. Saillant, MD, has the following relevant financial relationships:
    Consultant or advisor for: Haemonetics
    Research funding from: Haemonetics

  • Natalie Kreitzer, MD, MS

    Associate Professor of Clinical Emergency Medicine
    Neurocritical Care and UC Stroke Team
    Medical Director of Stroke Services
    West Chester Hospital
    University of Cincinnati
    Cincinnati, Ohio

    Disclosures

    Natalie Kreitzer, MD, MS, has the following relevant financial relationships:
    Consultant or advisor for: PhaseBio
    Speaker or member of speakers bureau for: Andexxa; AstraZeneca

Editor

  • Asha P. Gupta, PharmD, RPh

    Associate Medical Education Director, Medscape, LLC

    Disclosures

    Asha P. Gupta, PharmD, RPh, has no relevant financial relationships.

  • Frederick Stange, DO

    Scientific Content Manager, Medscape, LLC

    Disclosures

    Frederick Stange, DO, has no relevant financial relationships.

Compliance Reviewer

  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.


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    For Physicians

  • Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Aggregate participant data will be shared with commercial supporters of this activity.

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CME / ABIM MOC

Addressing Trauma Team Challenges in Bleeding Management and Reversal: Your Questions Answered

Authors: Noelle N. Saillant, MD; Natalie Kreitzer, MD, MSFaculty and Disclosures

CME / ABIM MOC Released: 9/13/2022

Valid for credit through: 9/13/2023

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Activity Transcript

Noelle N. Saillant, MD: Hello, I'm Dr Noelle Saillant. I'm a trauma and critical care doctor at Boston Medical Center in Boston, Massachusetts. Welcome to the program titled "Addressing Trauma Team Challenges in Bleeding Management and Reversal: Your Questions Answered." Joining me today is Dr Natalie Kreitzer, associate professor of Emergency Medicine, Neurocritical Care, and the medical director of Stroke Services at West Chester Hospital in Cincinnati, Ohio. Welcome, Dr Kreitzer.

Natalie Kreitzer, MD, MS: Thank you.

Dr Saillant: Today, we're talking about the burden of oral anticoagulant (OAC)-related major bleeding events in the ED (emergency department). OACs are increasingly being used by older patient populations due to their efficacy in preventing thromboembolic events, while having a decreased risk of spontaneous hemorrhage compared to more classic anticoagulants, such as warfarin. However, despite that, these medications still increase the baseline risk of bleeding, morbidity, and mortality. It's estimated that up to 20% of spontaneous intracranial hemorrhage events are associated with OAC therapy, and in 2017, OAC-related major bleeding accounted for 15.5% of ED visits for adverse drug events. 

Now, Natalie and I are going to discuss some of the frequently asked questions about managing OAC related bleeding.

Dr Kreitzer: Thank you. The first question we're going to discuss is a question that comes up quite frequently, which is: which bleeds require urgent treatment, and specifically, which patients should receive attempts at reversal for their oral anticoagulant use?

Now, there are several ways that bleeding is classified, and one of the most common ways to think about bleeding classifications is whether it is in a critical site or critical organ, meaning even just a small amount of bleeding will not be tolerated and highly increase the risk of morbidity and mortality, versus if it's considered more major bleeding. Now specific to my role in the neurointensive care unit, taking care of patients with traumatic and non-traumatic intracranial hemorrhages, that's certainly the most frequent type of hemorrhage that I take care of. And that would be in a critical site, that would be intracranial. Other critical sites that are less common than intracranial are going to be anywhere else in the CNS, such as an example, spinal epidural hematoma, pericardium, the airway, hemothorax, intra-abdominal, retroperitoneal, or in the extremities such as compartment syndrome. Certainly those are less common but can happen. 

I'm going to let Dr Saillant talk a little bit about major bleeding and the trauma patients.

Dr Saillant: Yeah. We have similar considerations in the trauma patient. Again, sites that are constricted, like the pericardium, are key, as well as extremities like compartment syndrome. The other thing that's important is how surgically accessible is the area that's bleeding? For instance, the retroperitoneum, the pelvis, retrohepatic liver are all difficult areas to control bleeding, and so we'd be much more expeditious in terms of reversal. Sometimes things like solid organ injuries, in the absence of hemodynamic instability, we might wait on reversal in consideration of what agent the patient's on and how they're doing hemodynamically.

Dr Kreitzer: Yeah, that's a great way to think about it. It's important to keep in mind that a lot of the bleedings that you may come across in patients are going to be considered non-major, and a common one certainly that I see in the emergency department is a GI bleed that's certainly not a massive amount of hemorrhage and just more of a nuisance GI bleed, for example. Those are the type of patients that you may not need to reverse the anticoagulation.

The second question that we'll talk about is how do you work these patients up, with the question being: how do you even detect now the effects of antithrombotic therapy, particularly with a lot of the newer agents, the direct oral anticoagulants? I'll let Dr Saillant talk a little bit about some of those ways.

Dr Saillant : Really, how we detect the effects of antithrombotic therapy are really having a high index of suspicion or having a patient history that they've recently taken one of these agents. Elevation of the PT and PTT are unreliable. Sometimes they may be elevated, sometimes they may not be. And currently, there is off-label use of viscoelastic assays that may detect that they've been on a DOAC. We're currently undergoing studies at this time. Hopefully we will come up with some universal detection assays, but nothing is currently being used in clinical medicine, aside from viscoelastic assays and the PT and PTT.

Dr Kreitzer: Yeah, I agree. A lot of that history, sometimes, especially in our patients in the neuro ICU, that can be quite challenging to obtain, since many of them are not able to provide that history to us. So, oftentimes that does involve us asking around, talking to family, pharmacies, really digging through history and trying to figure that question out.

Now, another thing that's important in terms of thinking about how do you work these patients up is assessing that bleeding severity, and that can be done just with the initial assessment that we do in any patient once you arrive to the emergency department. Focused history, physical exam, vital signs, looking at those labs, and then assessing that hemodynamic instability as soon as possible. Some other things that are really important to consider when we're thinking about direct oral anticoagulants are that time that the patient last took the medication, or at least the estimated time that they last took it, and other comorbidities that could contribute to bleeding or affect management. For example, in the Xa inhibitors, renal insufficiency may prolong the plasma concentration, for example. The overlying goals, of course, with this initial workup and management are to try to achieve hemostasis and preserve organ function.

Dr Saillant: Next, we're going to talk about initiation of the DOAC reversal based on timing of the last dose, and as Dr Kreitzer said, it's really important to note if they have renal insufficiency because this can sometimes extend out the half-life of some of these agents. Listed on this particular chart is going to be the more classic half-lives. So, you can see for dabigatran usually we think about dosing idarucizumab if they've been given the last dose with 8 to 12 hours. If idarucizumab is not available, then we'll think about prothrombin complex concentrate (PCC) as a second-line agent, although this is off-label. Similarly, the time for rivaroxaban or apixaban is about 18 hours from time of ingestion. However, the reversal agent for the Xa inhibitor is going to be andexanet alfa, with the second-tier agent being PCC. Edoxaban and betrixaban are also similarly treated with andexanet alfa and PCC as second-line agents.

Question 3 is going to be about the optimal reversal strategies, and we'll talk about the expert consensus decision pathways.

Dr Kreitzer: There are several different ways to look at this. There's a 2020 ACC Expert Consensus Decision Pathway, another guideline that's commonly utilized is the 2019 Anticoagulation Forum guidance statements. Just in general, guidelines have been updated looking at these specific questions pretty frequently over the past several years, just given that there's been a lot more newer data that's coming through.

Walking a little bit through that 2019 Anticoagulation Forum guidance statement, for dabigatran, the reversal agent that's recommended is idarucizumab 5 g IV, and if not available, activated PCC is 50 units/kg IV. For rivaroxaban or apixaban, it's recommended andexanet alfa, dosing according to the US FDA label, and if that's not available, 4-factor PCC 2000 units. For edoxaban and betrixaban, it's considered off-label treatment to give the andexanet alfa simply because those two agents were not in the trial that the FDA label utilized to get through, so that's the reason that it is listed as off-label andexanet alfa. And then otherwise, if unavailable, 4-factor PCC 2000 units.

When we think about the European Stroke Organization Forum, which is specifically for intracerebral hemorrhage, those guidelines are pretty similar. They do also include the vitamin K antagonists, such as warfarin, and in that case, PCCs are preferred over fresh frozen plasma, just given how much faster the INR can be corrected with PCCs. It's important to keep in mind as well in patients who are on vitamin K antagonists, that they also require vitamin K 10 mg IV in addition to the PCCs.

Dr Saillant: Question 4 is really how to get the reversal therapy to the patient quickly. Do you guys use a multidisciplinary approach at your institution?

Dr Kreitzer: Oh, absolutely. Yes, yes. One of our first calls is through our pharmacist, actually.

Dr Saillant : Yeah. It's similar here too, where we really use the treating team, whether it's the ED, the trauma team surgical team, as well as the pharmacy team, and sometimes we even involve hematology if needed as well. The other thing that's probably important to mention is really having kind of predetermined guidelines at your institution about how to do this quickly. A lot of these patients are going to really present in a kind of urgent or critical standpoint, and time's going to be of the essence to get them rapidly treated.

Dr Kreitzer: Yeah. So having a lot of those plans in place and protocols beforehand is pretty critical. Now, the reason we're discussing all of this is because there are a number of factors that complicate the use of reversal agents when it comes to clinical practice. One of these is that the availability varies by hospital. As a lot of these newer agents were rolled out, they were not rolled out universally to everywhere. There are risks anytime you reverse anticoagulation in a patient who's anticoagulated of thrombosis. Costs and preparation. Again, really emphasizing getting the pharmacist on board to help with some of that preparation and really understanding which patients benefit the most. And then, this is certainly an area where there's a lot new emerging data, so there's less comparative efficacy data, and then, although FDA approved, again, more data always coming out on these topics.

Dr Saillant: Question 5, when should you resume anticoagulation? This is always a really tricky one on our service and debated between teams. How do you guys approach this?

Dr Kreitzer: Oh, it's the same way. It's never super easy and straightforward, and I agree, having that team approach and really getting everybody on board and thinking through the risks and benefits for each patient is pretty important, because, really, no two patients are quite the same when you think about resuming anticoagulation.

Dr Saillant: Yeah, and some things that we think about surgically about resuming this is obviously, again, that critical site. Somewhere within a closed space like CNS or spinal cord, obviously we have a much higher threshold to restart, also difficult to access places within the abdomen, retroperitoneum, as we previously discussed, and then the risk of rebleeding. Finally, every once in a while, we get stuck with a patient that just, you can't find the source of bleeding, like that GI bleed patient that you mentioned earlier in the program. So those patients, maybe, again, we won't restart until we're sure we have source control and that the patient's hemodynamically doing fine.

Dr Kreitzer: Yeah. Never an easy answer to this question, and it really is, I think, the team approach of really discussing the risks and benefits of restarting versus not restarting.

Dr Saillant : I think we'll say a couple summary points. I think the first thing is, it's important to have predesignated guidelines in each of your institutions to make sure that each provider is facile with how to reverse this quickly in the event of emergency or significant bleeding.

Dr Kreitzer: Yeah. And this is a really exciting area of medicine right now. There's a lot more information coming out, a lot more data coming through, so certainly something to stay tuned in the coming years.

Dr Saillant: Well, I really want to thank you, Dr. Kreitzer, for this great discussion. It's always a pleasure.

Dr Kreitzer: Thank you.

Dr Saillant: And thank you, to the audience, for participating in this activity. Please continue to answer the questions and complete the evaluation.

This transcript has not been copyedited.

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