Prevalence and Outcomes Associated with Idarucizumab Administration in Trauma Patients on Preinjury Dabigatran Therapy: Analyzing Clinical Utilization in 942 Patients from 74 Hospitals

Background Increasing numbers of injured patients taking dabigatran are presenting to trauma centers raising an important clinical question: Does reversal with idarucizumab outweigh potential bleeding risks associated with dabigatran? The purpose of this study was to describe the prevalence of idarucizumab administration in trauma patients and compare outcomes for those who received reversal to those who did not. Methods This retrospective cohort study included trauma inpatients >18 years on preinjury dabigatran. Patients were sourced from the registries of Level I–IV trauma centers with an arrival date 1/2017–12/2021. Preinjury dabigatran therapy and idarucizumab administration were confirmed via EMR chart review. Patients on preinjury dabigatran were grouped according to administration status of idarucizumab. Results 942 trauma patients on preinjury dabigatran (49.7% male; mean GCS:15; >70 years: 85.7%) were included, with 10.8% patients reversed with idarucizumab. No statistically significant differences were found for preinjury dabigatran dose (p=0.703), age (p=0.494), blunt injury type (p=0.070), or mechanism of injury (p=0.248). Those reversed with idarucizumab had a greater median head AIS score (3 vs 2; p<0.001), higher proportion full trauma activations (16.7 vs 8.7%; p=0.019), higher median ISS (10 vs 9; p<0.001), were more likely to have a GCS 3–8 (4.9% vs 0.8%; p=0.006), and had increased rates of blood transfusion (4.9% vs 1.3%; p=0.022), ventilator use (10.8% vs 4.7%,p=0.009), and mortality (expired+hospice) (10.8% vs 4.9%; p=0.021). There was no difference between groups for thromboembolic events (1.0% vs 0.7%; p=0.553), hospital LOS (3 vs 4 days; p=0.147), or ICU LOS (3 vs 3 days; p=0.714). Conclusions In this large, retrospective cohort study of trauma patients, only 10.8% had reversal with idarucizumab. Patients reversed were more severely injured, with increased ICU and ventilator use, more transfusions ≤24 hours, and had increased mortality compared to those not reversed. There was no difference in thromboembolic events between groups. These findings suggest clinicians may be administering idarucizumab based on injury severity – especially head trauma – regardless of other variables, such as comorbidities. Additional research is needed to determine the optimal role of reversal with idarucizumab vs. other strategies for injured patients on dabigatran. What is new? What are the clinical implications? ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The authors have no conflicts of interest to declare. All co-authors have seen and agree with the contents of the manuscript and there are no financial interests to report. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board (IRB) of the University of Tennessee Health Science Center waived ethical approval for this work and determined it to be exempt from IRB oversight. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The authors had full access to all data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. * DOAC : direct oral anticoagulants FDA : Food and Drug Administration DVT : deep vein thrombosis PE : pulmonary embolism TBI : traumatic brain injury NSTEMI : non-ST elevation myocardial infarction ED : emergency department MOI : mechanism of injury ICD-10-CM : International Classification of Diseases, Tenth Revision, Clinical Modification EMR : electronic medical record MAR : medication administration record EDW : electronic data warehouse ICU : intensive care unit LOS : length of stay, reported in days IRB : institutional review board STROBE : Strengthening the Reporting of Observational Studies in Epidemiology ISS : injury severity score IQR : interquartile range GCS : Glasgow Coma Score AIS : abbreviated injury score