Mini Journal Club – Prothrombin Complex Concentrate

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Nurses Edition Commentary

Mel Herbert, MD MBBS FAAEM, Lisa Chavez, RN, and Kathy Garvin, RN
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brendanC -

Love David's simple-simon analogy for surrogate markers (cholesterol and MI/CVA)
Trying to have a patient oriented outcome is impossible except for mortality.
Feel like having the patient oriented outcome of decreased bleeding is too difficult to actually measure with so many types of "major bleeding"

Endocopy for UGIB is easy. Hematoma size in Musc/Skel bleeds, Size of bleed for ICH. no so much. With these we have to look at surrogate markers for stopping bleeding rather than....stopping bleeding. Big difference.
Great Journal Club. Am now glad my push for K-Centra was nixed by admin when it came out via emrap in 2013.

clay -

Dr Neumann, you are one of my all time heroes, but i think you're becoming a complete nihilist.

Medicine is about a lot more than death and survival, and many of the NNTs, for example, we have available to us do not account for the complex multiple different outcomes we may be aiming for (ie. cath in NSTEMI doesn't save lives, but does it improves systolic fxn, exercise capacity, reduce chest pain episodes, improve quality of life?? All important outcomes to patients...no available NNT).

In using PCC, maybe there are things other than mortality benefit we are trying to accomplish.

In this entire discussion you failed to mention the single reason why PCC is so valuable. Every single head bleed (and most major bleeds) on VKA i see, I transfer. Sometimes helicopters aren't flying bc we live in the mountains. It takes my hospital at least 1 hour to get FFP thawed and hung.

Do I delay their transfer to wait for FFP? Do I just give them nothing and transfer them?? When they arrive it will then take another 45 minutes or so to get FFP going?

I can give PCC and vitamin K in 10 minutes and then ship. I wish it resulted in improved survival, but thats not why i give it.

So the real questions:
"Is reversal indicated at all in VKA major bleeding?"
And "Is early reversal better than delayed?" I think the literature is clear that both of these answers are yes.

If your personal answer is yes to either of these questions, and you dont have an hour to wait to get the FFP even started, the PCC is an amazing alternative.

Especially if its safe, and doesn't increase VTE events versus FFP, which it doesn't appear to do.

I use PCC pretty commonly in these cases, unapologetically.

Disclosure: I would never disagree openly with anyone on EMRAP, especially Dave Neumann, who is one of the most influential thinkers on me personally over the years. Id get torn apart!

Just food for thought, and a reminder that theres more to the puzzle than primary endpoints like death, and time to stop bleeding etc. Pragmatic goals and incremental improvements in outcomes and patients quality of life are not addressed typically in this way of thinking (NNT).

dch -

Excellent review- similar to the previous comment, I face the same dilemma when I have a VKA patient with intracranial bleed-- the nearest neurosurgeon is at least 1 hour away, so they require transport by air.

I found only 1 study that compared FFP and PCC for intracranial bleeds: PMID: 24953825. It is very small and they assigned 28 to FFP and 5 to PCC - not randomized. The endpoint they focused on was decreased time to perform evacuation when using PCC.

Let me know if there is a study that you know of that looks at intracranial bleeding- including trauma patients. In a perfect world, there would be one that looked at endpoints of neurologic recovery or even neurosurgical intervention as endpoints, but I'm guessing we don't live in a perfect world. Thanks again and keep up the quest for truth.

Rob O -

Here are a few references on ICH and VKA

Observational study of VKA ICH patients. Half given PCC and half . Rapid INR reversal with PCC . Getting PCC in quickly had benefit on ICH expansion. Kuwashiro, Takahiro, et al. “Effect of prothrombin complex concentrate on hematoma enlargement and clinical outcome in patients with anticoagulant-associated intracerebral hemorrhage.” Cerebrovascular Diseases 31.2 (2010): 170-176.

An observational study on ICH patients taking VKAs. The main conclusion one can draw from this paper is that VKA patients with ICH have a poor outcome. In this study, 76% composite end point of death of disability (mortality around 40%). Most patients were reversed and reversal didn’t seem to have an impact on outcome, but this was observational and not a controlled trial. de Leciñana, M. Alonso, et al. “Questionable reversal of anticoagulation in the therapeutic management of cerebral haemorrhage associated with vitamin K antagonists.” Thromb Haemost 102.1 (2009): 42-48.

Horstmann, S., et al. “Intracerebral hemorrhage during anticoagulation with vitamin K antagonists: a consecutive observational study.” Journal of neurology (2013): 1-6.

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