Education Blog for Healthcare Professionals

Pradaxa (Dabigatran) – Hospital Guideline

The new oral anticoagulant Pradaxa® (Dabigatran) is increasingly being used as an alternative to warfarin.   A number of practical management questions are now encountered by the physician, pharmacist, or other health care professional taking care of the patient on Pradaxa®, such as (a) dosing in renal impairment, (b) conversion of a patient on warfarin to Pradaxa®, (c) discontinuation of Pradaxa® at times of surgery, dental work, colonoscopy, or other procedures, or (d) management of bleeding on Pradaxa®.   These issues may best be addressed in a health care system by the establishment of a structured treatment algorithm/guide/help for the whole hospital or physician practice. As an example, here is the document that we have established for our institution, the University of North Carolina (UNC) Health Care System.  The reader is welcome to (a) take the document and modify it to fit his/her institution/practice’s need or (b) use as a clinical reference for management issues. Also, a detailed discussion of various Pradaxa® issues can also be found in this Clot Connect blog:

  • Pradaxa® use in patients with DVT or PE: click here
  • Management of major bleeding on Pradaxa®: click here
  • Pradaxa®  interruption for procedures and surgeries: click here

Disclosure: I have no financial conflict of interest relevant to this educational post.

Last updated: May 1st, 2012

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9 Responses to “Pradaxa (Dabigatran) – Hospital Guideline”

  1. Dr Lachie Hayes says:

    Congratulations Dr Moll, this guideline is a fantastic resource which I will certainly discuss with our local group! The practical issue of what to do when patients present with major bleeding on the newer anticoagulants seems to have taken second place to the excitement of an oral agent that does not require monitoring. The trial publications have been notably silent on this issue. I fear that enthusiasm may soon turn to confusion when ED and perioperative physicians are faced with real dilemmas about what to when things go badly.
    Are you planning to develop similar guidelines for rivaroxaban (Xarelto) at your institution?

    • Stephan Moll says:

      Thank you. Whenever another new oral anticoagulant becomes available we will make an effort to develop a similar guideline and make it available through Clot Connect. I suspect the next agents to come into clinical practice in the U.S. will be Rivaroxaban (Xarelto), then Apixaban (Eliquis) and then Edoxaban.

  2. Ben H. Quinney, Jr, MD says:

    This is really good, useful stuff.

    Similar guidelines/advice regarding Fondaparinux also would be helpful.

    Thanks.

  3. Tina Hipp says:

    What do you think about an outpatient protocol for Pradaxa, feeding patients into our anticoagulation clinics?
    It would include for example:
    1. MD identifies patient who is a possible Pradaxa candidate. Patient is sent to coordinated system, such as anticoagulation clinic.
    2. Clinic evaluates patient for appropriateness for Pradaxa (including evaluation of renal function, drug interactions, bleeding, compliance, duplicate anticoagulant therapy). Patient also gets educated on Pradaxa and explained the b.i.d. dosing, drug interactions, no way to reverse, insurance and patient cost, procedural directions etc…
    3. Patient switched from Warfarin to Pradaxa if on Warfarin prior to appointment.
    4. Patient brought back in 4-6 weeks to evaluate if having any issues, bleeding, compliance etc…
    5. Patient loosely followed at this point. Clinic available if patient needs to go off for procedure and helps patient go off and on drug based on guidelines.
    What do you think?

    • Stephan Moll says:

      1. Take with food, not on a completely empty stomach. Take at breakfast and at dinner…good way to do the 12 hour apart schedule.
      2. Also: It appears that in a number of poeple the body adjusts after a few weeks. Give it a little time (a few weeks).
      3. I also suspect…though no evidence…that there is also some exacerbation of dyspepsia if one is also taking other medications, perhaps at the same time of the Pradaxa dose. I wonder if staggering, when one takes other medications (including vitamins, over-the-counters, etc.), might be helpful. In other words, when you take the Pradaxa, you only take the Pradaxa and nothing else.

    • Stephan Moll says:

      I would expect Dabigatran to be as effective as Warfarin in patients with protein C or S deficiency and thrombosis, judged by (a) the mechanism of action of Dabigatran, and (b) the fact that warfarin-treated patients with these thrombophilias do not require a different target INR compared to patients without these thrombophilias. At this point I do not know of patients with these thrombophilias who are on Dabigatran. Furthermore, no national database or other mechanisms to identify such patients exist.