All posts by TheTraumaPro

Life Threatening Bleeding In The Anticoagulated Patient – Part 3

Over the last two posts, I’ve explored some of the current definitions of “life-threatening bleeding” and shared my own take on a simplified yet more universal definition. So how can we put this into practice?

In the trauma world, we typically need to use this definition when dealing with patients who are taking anticoagulants. When a patient on this class of drug arrives at your center after trauma, they must be evaluated promptly. This is frequently in the form of a trauma activation, which provides rapid access to labs and imaging. If the patient does not meet activation criteria, some type of expedited response (limited activation or rapid evaluation by emergency physician) is required. The most important decision that must be made is, “does this patient need to have their anticoagulant reversed?”

This decision depends on the answers to the two criteria I laid out in the last post. Is either of these present?

  1. (Physiologic) Bleeding that causes hemodynamic compromise (hemorrhagic shock) or changes in vital signs indicating progression toward it (increasing pulse rate, decreasing blood pressure).
  2. (Anatomic) Bleeding into a body region or tissues that has a high likelihood of causing death, disability, or the need for operative intervention.

The first one is easy. Actual or developing hypovolemic shock should be obvious to any clinician managing the patient.

The second one is not necessarily as apparent. Although one may think that any intracranial blood may be life-threatening, sometimes it is not. What about a little subarachnoid hemorrhage? Or a tiny subdural in an area that typically does not progress?

So how to we determine if definition 2 is met? Phone a friend. Call an expert. There are so many potential areas for this type of bleeding to occur, a single emergency physician or other clinician may not be able to accurately make this judgment. So call your friendly, neighborhood neurosurgeon (head), or surgeon (abdomen, soft tissues), GI specialist (UGI bleed), or obstetrician (baby stuff). If they agree that it is life-threatening, the reverse the anticoagulant.

This level of oversight is important, because the reversal agents are not totally benign, or cheap. They have known complications, and one rare but important one is death. So make sure that their use is justified.

Final tips: Once you have determined that reversal is required, use the fastest agent(s) available. For warfarin, this means prothrombin complex concentrate (PCC) and not plasma. Typically, plasma reversal requires at least 4 units, and this takes hours. PCC takes 30 minutes or less. 

Document your judgment well, and your conversations with specialists who are helping you with definition #2. This is critical, because there have to be checks and balances for use of your rapid reversal protocols. There must be a post hoc analysis of each and every reversal, just like there should be for use of your massive transfusion protocol. A group of knowledgeable clinicians must review the clinical information that was available at the time of presentation, and render their agreement or disagreement to provide a good feedback loop and ensure proper usage of these products.

 

What Is: Life Threatening Bleeding In The Anticoagulated Patient – Part 2

In my last post, I showed you some of the current definitions of “life-threatening” bleeding used in patients who are anticoagulated, as well as some for lesser degrees of bleeding. Confusing, right? How are we to ever know what is truly life-threatening so we can justify intervention/reversal with potent and/or expensive drugs and blood products?

It’s time for a more universal definition. The most important thing to recognize up front is that it is absolutely impossible to provide a comprehensive set of definitions that take every possible scenario into account. The list would be confusingly long. We really only need a few rules that are a bit more generalized. But then, how do we keep providers from just doing what they want, and coming up with some subjective or anecdotal justification? Bear with me for a day or two.

Today, I’ll lay out my two “universal definitions” of significant bleeding in an anticoagulated patient. Note that I didn’t say “life-threatening” bleeding. There is also such a thing as “limb-threatening” or “tissue-threatening” bleeding, and yet other ways to be harmed from uncontrolled bleeding due to anticoagulants.

If you look through all the various criteria that I included in the last post, you can see that they generally fall into two categories: physiologic and anatomic. The key is to reach a balance of being specific enough without being overly so. This still allows for some degree of clinician judgment. But as you will see in my next post, there also has to be some type of scrutiny and review of that judgment.

So here is what I propose. Bleeding is considered significant and/or life-threatening if either of these are true:

  1. (Physiologic) Bleeding that causes hemodynamic compromise (hemorrhagic shock) or changes in vital signs indicating progression toward it (increasing pulse rate, decreasing blood pressure).

  2. (Anatomic) Bleeding into a body region or tissues that has a high likelihood of causing death, disability, or the need for operative intervention.

In my next post, I’ll show you how to operationalize these definitions into a workable process for making decisions about reversing anticoagulation.

 

What Is: Life Threatening Bleeding In The Anticoagulated Patient – Part 1

We are moving into a world where more and more people are taking anticoagulants. And as the number of possible anticoagulant drugs increases, the prospect of reversing them becomes more complicated. Just as the price of those medications continues to climb, so does the price of the agents used to reverse them.

The decision to reverse an anticoagulant, the speed of reversal, and choice of reversal agent all depend on an assessment of the severity of bleeding. Some reversal drugs such as prothrombin complex concentrate (PCC) act almost immediately but are expensive. Others take time, but are cheaper such as plasma and vitamin K.

Unfortunately, trying to come to a consensus on what constitutes life-threatening bleeding is very difficult. Over the years, numerous studies have been done, with almost as many definitions of bleeding. As you know, I am generally against reinventing the wheel. Borrowing someone else’s excellent work saves a lot of time and anguish.

But when it comes to defining dangerous bleeding, we are faced with so many definitions, it just begs for a “unifying theory.” I’ll show you some of the more commonly used definitions below. At the very bottom, I’ve included a link to a very comprehensive list of definitions that have been used.

First, there’s TIMI (Thrombolysis in Myocardial Infarction trial) and GUSTO (Global Use of Strategies to Open Occluded Arteries trial). (Please remember how much I dislike cute acronyms.)

The following consolidated definition was published in the Journal of Thrombosis and Haemostsis way back in 2005:

If you want to look at a more comprehensive list of a lot of definitions, download the document from the link below.

So how do we make sense of all this? As trauma professionals and clinicians on the front line of anticoagulant reversal, we need a simple definition. I’ve recently looked over as many definitions as I could lay my hands on. 

In my next post, I’ll propose a simplified set of definitions. And I’ll be very interested in your input and comments. They will ultimately end up as a definition that we will use at my own trauma center. And maybe yours.

Related post:

Reference:

  • Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. Journal of Thrombosis and Haemostasis, 3: 692–694, 2005.

When Does The PI Clock Start Ticking? The Answer, Part 2!

I analyzed the first of two PI clock scenarios in my last post. They are not always as obvious as they seem. Now let’s look at the second case:

A young male is involved in a motor vehicle crash and strikes his head. He enters your trauma center at exactly midnight as a trauma activation. Head CT shows a 7mm epidural hematoma with no shift and no effacement. GCS is 15, and the neurologic exam is completely normal. He is admitted to the SICU for neuro monitoring and is scheduled to have a repeat CT scan at 06:00. The scan shows significant expansion of the hematoma, with midline shift and ventricular effacement. He is taken to the OR for craniotomy by neurosurgery at 6:55.

This one is very similar to the first, except there is no indication to go to the OR at initial presentation. But about 7 hours later, he is in the operating room. So the PI trigger occurs, right? That’s more than 4 hours!

Not so fast! Let’s analyze this a bit more. Everything seems to be going well until the 6 AM CT scan. If the patient’s condition is unchanged, the earliest possible time the change in his head could have been recognized was shortly after 6:00. So the patient was actually in the OR less than an hour after the problem was recognized, right?

Not quite so fast again. The trauma PI program still has to examine the entire process from arrival until operation. Here are the questions that need to be answered:

  • Was neurosurgery involved in the initial evaluation in a timely manner?
  • Was the patient admitted to an appropriate inpatient unit?
  • Did appropriate monitoring occur?
  • Did any change in exam occur that could have suggested the hematoma was changing?
  • If so, did nursing and physician staff act appropriately with that information?

Bottom line: If everything went according to plan, and there was no change in exam or vital signs through the repeat CT scan, then this is an exemplary catch, and instead of sending the usual trauma PI nasty-gram to neurosurgery, they should receive a congratulatory note for providing such excellent service!

All too often, the trauma program just routinely sends out these “nasty-grams” without doing any further analysis of the data. And in cases like this one, the work involved in responding is just a waste of time. 

General rule: If the actual time noted for one of these time-sensitive filters is very, very long (e.g. delay to laparotomy of 62 hours), then look at it very closely. Did someone actually sit on a bleeding spleen for nearly three days, of was the patient doing well and suddenly failed nonoperative management? I think you know the answer.

And don’t forget to send out a few love letters to the other services for work well done from time to time! They probably cringe when they see trauma PI notes, since they always seem to imply something bad has happened.

When Does The PI Clock Start Ticking? The Answer, Part 1!

In my last post, I presented two potential performance improvement (PI) cases. I asked for your input as to when the clock should actually start for the 4-hour craniotomy/craniectomy rule. Today, I’ll give you my answer to the first case.

Lets look at it again:

A young male is involved in a motor vehicle crash and strikes his head. He enters your trauma center at exactly midnight as a trauma activation. Head CT shows a 12mm epidural hematoma with 8mm midline shift and ventricular effacement. GCS was 14 on arrival, but has declined to 12 by the time you leave the CT scanner. He is taken to the OR for craniotomy by neurosurgery at 4:15.

This one looks straightforward, right? But not so fast. The crani occurred more than 4 hours after arrival. Isn’t that a violation of the 4 hour filter? But did you know he needed an operation when he arrived in the ED? No! GCS and exam were reasonable, so the clock starts once the CT scan finishes, even if the surgeon doesn’t see them at that time. Why then? because the 4 hour rule is testing all of the following:

  • Whether a physician was present in CT and recognized what was on the images (not required, but reviewed if there was one there)
  • How long it takes for the radiologist to get the images
  • How long it takes for the report to be done
  • How quickly the surgeon or emergency physician review the report
  • How long it takes to contact the neurosurgeon
  • How long it takes them to see the patient and decide they need an operation
  • How easy it is to get this emergency case to the OR suite
  • How long it takes for anesthesia to do their assessment and get the patient into the room
  • How long it takes the OR team to be ready to cut

Lots of stuff! So if the scan finished any later than 12:15 am, this filter gets triggered. But hold on! In my opinion, 4 hours is a long time to wait for an emergent problem like this large epidural. Even if the scan finished at 12:30, the 4 hour rule is met, but why did it take so long to get the operation started? I’ve seen cases like this where the incision was started less than an hour after the patient arrived in the trauma bay!  Some of these cases need review even if they appear to meet the time limits.

Bottom line: Case #1 – the clock officially starts when the proof of clinical injury has been provided. This could be an abnormal physical exam, a CT scan, a critical lab test draw, a phone call from a concerned nurse, etc. The clock doesn’t necessarily start when the patient rolls in the door, unless you have some kind of weird superpowers!

I’ll review and analyze the second case tomorrow.