Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
Condition: Severe Bleeding; Urgent Surgery
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as
      Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need
      urgent interventions/operations that cannot wait are included in this registry, or during
      emergency operations.
    

Detailed description: 
      The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC,
      aPCC, rVIIa, specific antidots in e.g. severe bleeding patients treated with oral
      anticoagulants.

      By collecting case reports from several university hospitals and clinics, different treatment
      strategies in clinical practice will be observed and evaluated, and may serve as a
      comprehensive information resource for the safe management with DOA, but also with the
      long-term anticoagulation based on coumarin derivatives in the near future.

      The current objective of this registry is to:

        1. Document the clinical course and outcome of various clinical bleeding events associated
           with DOA or VKA in patients with severe life-threatening bleeding making intervention
           necessary

        2. Document the clinical course and outcome of urgent surgical interventions within 24
           hours after admission in patients under DOA or VKA treatment.

        3. Characterisation of therapeutic strategies in stopping acute life-threatening bleeding
           including following agents and methods:

             1. blood transfusion,

             2. platelet concentrates

             3. reversal agents [e.g. vitamin K, prothrombin complex concentrate (PCC), activated
                PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen
                plasma (FFP)]

             4. specific antidots, e.g. idarucizumab

             5. haemodialysis

             6. desmopressin

             7. tranexamic acid

             8. no specific treatment in respect to the above mentioned treatments (e.g. stop of
                medication and waiting until anticoagulant effect of DOA is decreased).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Expected number of patients estimated by study duration

        N= 90 patients treated with direct oral anticoagulants (DOA) with acute bleeding N= 90
        treated with vitamin K antagonists (VKA) with acute bleeding

        N= 40 patients treated with direct oral anticoagulants (DOA) with urgent surgical
        intervention N= 40 patients treated with vitamin K antagonists (VKA) with urgent surgical
        intervention
      
Biospecimen description: 
      If possible, left-over from plasma samples ("retention sample") should be used to perform
      further analyses as drug concentrations. Retention samples of very low volume would suffice
      for HPLC (information on collection method needed) to assess plasma concentrations of
      anticoagulants in these patients.
    
Keywords: severe bleeding; dabigatran; rivaroxaban; apixaban; edoxaban; PCC; aPCC; rVIIa; hemodialysis; antidots; idarucizumab