Impact of a Posttraumatic Cerebral Infarction on the Long-Term Outcome of Patients with Moderate and Severe Traumatic Brain Injuries: The Italian Multicenter Cohort INCEPT Study

Background: Post-traumatic cerebral infarction (PTCI) is common in patients dying after a traumatic brain injury (TBI). It is unclear what the occurrence of a PTCI is, how it impacts the long-term outcome, and whether it adds incremental prognostic value to established outcome predictors. Methods: This was a prospective multicenter cohort study of moderate and severe TBI patients admitted to nine Italian intensive care units (ICUs). The primary objective was to evaluate if PTCI was an independent risk factor for the 6-month outcome assessed with the Glasgow Outcome Scale (GOS). We also assessed the PTCI occurrence and if it adds incremental value to the International Mission for Prognosis and Clinical Trial design in TBI (IMPACT) core and extended models. Findings: We enrolled 143 patients; 47 (32·9%) developed a PTCI for a total of 94. The mean (SD) onset time of a PTCI was 6·2 (11·4). In the multiple ordered logistic regression, PTCI was retained in both the core and extended IMPACT models as an independent predictor of the GOS. The predictive performances increased significantly when PTCI was added to the IMPACT core model (AUC=0·73, 95% C.I. 0·66-0·82; increased to AUC=0·79, 95% CI 0·71-0·83, p=0·0007) and extended model (AUC=0·74, 95% C.I.: 0·65-0·81 increased to AUC=0·80, 95% C.I. 0·69-0·85; p=0·00008). Patients with a PTCI showed higher ICU mortality (10 patients [21·3%] vs one patient [1·0%], p<0·0001) and 6-month mortality (13 patients [27·7%] vs seven patients [7·3%], p<0·0001); whereas, hospital mortality did not differ between the two groups. Interpretation: A PTCI is a common complication in patients suffering a moderate or severe TBI and is an independent risk factor for long-term disability. The addition of PTCI to the IMPACT core and extended predictive models significantly increased their performance in predicting the GOS. Trial Registration Number: This study was registered with ClinicalTrials.gov (number NCT02430324). Funding Statement: The present study was self-funded. The authors declare "none" to funding. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The study was conducted in accordance with the Declaration of Helsinki and was approved by the local Ethics Committees of each participating center. Patients’ informed consent was waived due to the lack of definition of a legal representative of temporarily incapacitated adult patients in the Italian legislation.11 The informed consent was obtained from the surviving patients as soon as they regained their mental competency. Family members received detailed information on the study scope and protocol. We followed the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for reporting cohort studies.