In the TRACK trial, modified ISTH major bleeding is defined as:
- fatal bleeding, and/or
- symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, or bleeding into the surgical site requiring reoperation, and/or
- bleeding leading to hospitalisation.
If a participant experiences a major bleed (see above), the following measures could be considered, along with expeditious consultation with Specialist Haematologists:
- Local measures according to usual care (e.g. local pressure, endoscopy and injection of a bleeding vessel, embolisation).
- Usual supportive treatment, including intravenous fluids, blood transfusion.
- In case of life-threatening or uncontrolled bleeding, urgent specialist haematology consultation for consideration to use prothrombin complex concentrates (PCC), activated prothrombin complex concentrates (APCC) or recombinant factor VIIa, or reversal with andexanet alfa where available.
- Consider platelet transfusion in case of thrombocytopenia and/or if the participant is on aspirin.
- Treat concomitant coagulopathy if present.
Note that rivaroxaban cannot be dialysed as it is highly protein bound. Normal values of prothrombin time (PT), INR and activated partial thromboplastin time (aPTT) do not exclude an ongoing anticoagulant effect of rivaroxaban.