Urgent Surgery Clinical Trial
Official title:
Prospective, Observational, Non-interventional Open-Label, International, Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists
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
The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC,
aPCC, rVIIa, specific antidots in patients needing urgent interventions/operations or in
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, Andexanet alpha
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).
;
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