Bleeding Patients on Dabigatran aka Pradaxa

 Reversal of Dabigatran

 

The incredible folks from hqmeded have put up a video on how to deal with bleeding patients on the new oral anticoagulant, dabigatran…

 

 

Here is the Hennepin County Reversal Protocol from the Video

Hennepin County Dabigatran Reversal

What I took from this excellent resource:

  • Thrombin Time is probably the best available way to monitor this drug, but due to lack of lab standardization, we cannot establish non-institutional ranges
  • If aPTT is totally normal (<1.5x), unlikely that sig. drug effect is present
  • Can be dialyzed and ~60% will be removed at 2-3 hour mark
  • Despite the rec that FFP or PCC may be helpful, I am not sure why this would be the case. Factor VIIa or FEIBA seems the best choices, albeit not great or proven ones. I could totally be talking out of my arse, though.
  • Activated charcoal will adsorb this drug if the patient took it <2 hours ago.

Here is a great review article on dabi.

The blog Clot Connect MD put up these references:

References

  1. van Ryn J. Dabigatran etexilate – a novel, reversible, oral direct thrombin inhibitor: Interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010; 103: 1116–1127.
  2. Crowther MA. Managing bleeding in anticoagulated patients with a focus on novel therapeutic agents. J Thromb Haemost 2009; 7 (Suppl 1):107–110.
  3. Eerenberg ES et al. Prothrombin Complex Concentrate reverses the anticoagulant effect of Rivaroxaban in healthy volunteers (abstract 1094; ASH annual meeting Dec 4-7, 2010, Orlando, FL).
  4. Morishima Y et al. Anti-Inhibitor Coagulant Complex, Prothrombin Complex Concentrate, and recombinant factor VIIa reverse prothrombin time prolonged by Edoxaban in human plasma (abstract 3319; ASH annual meeting Dec 4-7, 2010, Orlando, FL)

and linked to another reversal protocol from UNC

great post from EM Lit of Note, pointing to a study that PCCs will reverse Rivaroxaban, but Not Dabigatran (these were non-activated PCCs AFAIK)

“Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate.” www.ncbi.nlm.nih.gov/pubmed/21900088

Leon Gussow of the Poison Review has another excellent post on the top 10 questions on Dabigatran

Just published study indicates that Dabi may not cause enlarged hematomas in head bleeds (Circulation 2011;124:1654-1662)

For a better understanding (if you are smarter than me) of how Dabigatran Etexilate affects lab assays, see this article Thromb Haemostasis 2012;107(5) Douxfils et al.)

New article confirms a normal PTT and INR means no sig. dabigatran on board (PMID:23232017)

Letter to editor stating aPCC reverse dabi (British Journal of Haematology, 2013, 164, 296–310)

You finished the 'cast,
Now get CME credit

Not a subcriber yet? Why the heck not?
By subscribing, you can...

  • Get CME hours
  • Support the show
  • Write it off on your taxes or get reimbursed by your department

Sign Up Today!

.

Subscribe Now

If you enjoyed this post, you will almost certainly enjoy our others. Subscribe to our email list to keep informed on all of the ED Critical Care goodness.

This Post was by , published 3 years ago. We never spam; we hate spammers! Spammers probably work for the Joint Commission.

Comments

  1. hope all is well this early summer. Curious if the patient gets hemodialysis w/o heparin if the patient has a head bleed? TT time means the same as prothrombin time as an assay? factor 7 versus PCC, unknown which is better. I am not sure why the FDA would approve such a drug w/o a clear antidote. I guess the next product on market would be recombinant Thrombin to give to patients.

  2. Jose,

    great question. have not seen data, but i believe he the dabi itself should be enough anti-coag for the HD. When the filter clots, you are probably ready to stop the dialysis. TT is different than PT, unfortunately, so regular coags prob not the way to go. If it was my head I would want the Factor VIIa, b/c I really don’t see why PCC would do anything. As to FDA, you could argue that ther. dabi may still be a better deal than the frequent head bleeds we see with crazy INRs in pts on warfarin.

  3. Brian says:

    Hi,
    Would you mind explaining your reasoning that Factor VIIa would be superior to PCC in this case?

    • My thoughts are (with the proviso, that i have no good evidence for any of this) that 3-factor PCC brings very little tot he table. None of these factors are in shortage with dabi and not sure how much thrombin for direct comptetition with dabi is going to be generated. 4-factor seems ok, b/c at least you have the VIIa, but why not just give the VIIa then in greater concentrations. This will get you the TF thrombin burst, which is probably where the money is. Also, putatively you are going to get direct plt activation with the VIIa preps. So my take, 3-factor PCC probably not worth it. 4-factor maybe, but if you have it available, why not go witht eh higher doses of VIIa in the specific product and +- FFP. What are your thoughts

    • FEIBA should work, however

      • Aaron says:

        Scott,
        Are you saying FEIBA should be better b/c it contains VIIa? And when you mention 4 factor PCC in the above comment isn’t that the same as FEIBA? Thanks for your help and clarification.

  4. Bryan Price says:

    As a relatively new patient taking this drug (3/11), this is important information to me. I just hope that if I do need to go into the ER with a bleed, they won’t be depending on me to figure it all out. O_o

    I have to say that I am not missing the monthly (or more frequent) trips to the cardiologist’s office for INR tests. And also dealing with my INR spikes and lows occurring without any changes in diet, and preparing for a procedure, although a pacer in Feb. has fixed what has been ailing me. If my next appt. goes well, I’ll only be seeing my EP yearly.

  5. Pete Capozzoli says:

    It has been a year and a half since I first read this website and listened to the video. Has anyone come up with any new strategies based on experience and experimentation? Thanks.

Trackbacks

  1. Pradaxa® – Management of Major Bleeding « Clot Connect MD says:

    [...] A well balanced and well explained audio-powerpoint presentation on Dabigatran, it’s action and reversal option of bleeding can be found here. [...]

  2. [...] Reversal of Dabigatran video This entry was posted in Pharmacology. Bookmark the permalink. ← Quiz: ALS 2011 #1    [...]

  3. […] Bleeding Patients on Dabigatran @ EMCRIT.org […]

Speak Your Mind (Along with your name, job, and affiliation)