Data entry option on antidote for dabigatran

Thursday, June 9, 2016


Idarucizumab (Praxbind) is a fully humanized, monoclonal antibody which is a specific antidote to reverse the anticoagulant effect of dabigatran etexilate (Pradaxa). Idarucizumab is approved in the USA and EU for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. SITS registry will provide an opportunity for centres to enter data on idarucizumab. Data entry for idarucizumab will be optional and available for all Standard e-CRF Protocol (iv thrombolysis, thrombectomy and general stroke registry). This will give the scientific community and clinician an opportunity to monitor and safe implementation of idarucizumab in routine clinical practice.

During the launch of idarucizumab related variables, we will also update 2 aspects of the intravenous thrombolysis dataset: 1) few variables related to unknown time of stroke onset and 2) few variables on dose per kg weight of intravenous alteplase.