Multi-centric study for development and validation of a CT head rule for mild traumatic brain injury in direct oral anticoagulants: the HERO-M nomogram.

BACKGROUND: Nomograms are easy-to-handle clinical tools which can help in estimating the risk of adverse outcome in certain population. This multi-center study aims to create and validate a simple and usable clinical prediction nomogram for individual risk of post-traumatic Intracranial Hemorrhage (ICH) after Mild Traumatic Brain Injury (MTBI) in patients treated with Direct Oral Anticoagulants (DOACs). METHODS: From January 1, 2016 to December 31, 2019, all patients on DOACs evaluated for an MTBI in five Italian Emergency Departments were enrolled. A training set to develop the nomogram and a test set for validation were identified. The predictive ability of the nomogram was assessed using AUROC, calibration plot, and decision curve analysis. RESULTS: Of the 1425 patients in DOACs in the study cohort, 934 (65.5%) were included in the training set and 491 (34.5%) in the test set. Overall, the rate of post-traumatic ICH was 6.9% (7.0% training and 6.9% test set). In a multivariate analysis, major trauma dynamic (OR: 2.73, p = 0.016), post-traumatic loss of consciousness (OR: 3.78, p = 0.001), post-traumatic amnesia (OR: 4.15, p < 0.001), GCS < 15 (OR: 3.00, p < 0.001), visible trauma above the clavicles (OR: 3. 44, p < 0.001), a post-traumatic headache (OR: 2.71, p = 0.032), a previous history of neurosurgery (OR: 7.40, p < 0.001), and post-traumatic vomiting (OR: 3.94, p = 0.008) were independent risk factors for ICH. The nomogram demonstrated a good ability to predict the risk of ICH (AUROC: 0.803; CI95% 0.721-0.884), and its clinical application showed a net clinical benefit always superior to performing CT on all patients. CONCLUSION: The Hemorrhage Estimate Risk in Oral anticoagulation for Mild head trauma (HERO-M) nomogram was able to predict post-traumatic ICH and can be easily applied in the Emergency Department (ED).

Risk of delayed intracranial haemorrhage after an initial negative CT in patients on DOACs with mild traumatic brain injury.

BACKGROUND: Repeat head CT in patients on direct oral anticoagulant therapy (DOACs) with minor traumatic brain injury (MTBI) after an initial CT scan without injury on arrival in the Emergency Department (ED) is a common clinical practice but is not based on clear evidence. AIM: To assess the incidence of delayed intracranial haemorrhage (ICH) in patients taking DOACs after an initial negative CT and the association of clinical and risk factors presented on patient arrival in the ED. METHODS: This retrospective multicentre observational study considered patients taking DOACs undergoing repeat CT after a first CT free of injury for the exclusion of delayed ICH after MTBI. Timing between trauma and first CT in the ED and pre- or post-trauma risk factors were analysed to assess a possible association with the risk of delayed ICH. RESULTS: A total of 1426 patients taking DOACs were evaluated in the ED for an MTBI. Of these, 68.3% (916/1426) underwent a repeat CT after an initial negative CT and 24 h of observation, with a rate of delayed ICH of 1.5% (14/916). Risk factors associated with the presence of a delayed ICH were post-traumatic loss of consciousness, post-traumatic amnesia and the presence of a risk factor when the patient presented to the ED within 8 h of the trauma. None of the patients with delayed ICH at 24-h repeat CT required neurosurgery or died within 30 days. CONCLUSIONS: Delayed ICH is an uncommon event at the 24-h control CT and does not affect patient outcome. Studying the timing and characteristics of the trauma may indicate patients who may benefit from more in-depth management.

"Decision tree analysis for assessing the risk of post-traumatic haemorrhage after mild traumatic brain injury in patients on oral anticoagulant therapy".

BACKGROUND: The presence of oral anticoagulant therapy (OAT) alone, regardless of patient condition, is an indication for CT imaging in patients with mild traumatic brain injury (MTBI). Currently, no specific clinical decision rules are available for OAT patients. The aim of the study was to identify which clinical risk factors easily identifiable at first ED evaluation may be associated with an increased risk of post-traumatic intracranial haemorrhage (ICH) in OAT patients who suffered an MTBI. METHODS: Three thousand fifty-four patients in OAT with MTBI from four Italian centers were retrospectively considered. A decision tree analysis using the classification and regression tree (CART) method was conducted to evaluate both the pre- and post-traumatic clinical risk factors most associated with the presence of post-traumatic ICH after MTBI and their possible role in determining the patient's risk. The decision tree analysis used all clinical risk factors identified at the first ED evaluation as input predictor variables. RESULTS: ICH following MTBI was present in 9.5% of patients (290/3054). The CART model created a decision tree using 5 risk factors, post-traumatic amnesia, post-traumatic transitory loss of consciousness, greater trauma dynamic, GCS less than 15, evidence of trauma above the clavicles, capable of stratifying patients into different increasing levels of ICH risk (from 2.5 to 61.4%). The absence of concussion and neurological alteration at admission appears to significantly reduce the possible presence of ICH. CONCLUSIONS: The machine-learning-based CART model identified distinct prognostic groups of patients with distinct outcomes according to on clinical risk factors. Decision trees can be useful as guidance in patient selection and risk stratification of patients in OAT with MTBI.

Minimal is not minor also in patients with mild traumatic brain injury on oral direct anticoagulant therapy.

Currently, all patients, regardless of the type of head injury, should undergo a head computerized tomography (CT) if on oral anticoagulant therapy. The aim of the study was to assess the different incidences of intracranial hemorrhage (ICH) between patients with minor head injury (mHI) and patients with mild traumatic brain injury (MTBI) and whether there were differences in the risk of death at 30 days as a result of trauma or neurosurgery. A retrospective multicenter observational study was conducted from January 1, 2016, to February 1, 2020. All patients on DOACs therapy who suffered head trauma and underwent a head CT were extracted from the computerized databases. Patients were divided into two groups MTBI vs mHI all in DOACs treatment. Whether a difference in the incidence of post-traumatic ICH was present was investigated, and pre- and post-traumatic risk factors were compared between the two groups to assess the possible association with ICH risk by propensity score matching. 1425 with an MTBI in DOACs were enrolled. Of these, 80.1% (1141/1425) had an mHI and 19.9% (284/1425) had an MTBI. Of these, 16.5% (47/284) patients with MTBI and 3.3% (38/1141) with mHI reported post-traumatic ICH. After propensity score matching, ICH was consistently found to be more associated with patients with MTBI than with mHI (12.5% vs 5.4%, p = 0.027). Risk factors associated with immediate ICH in mHI patients were high energy impact, previous neurosurgery, trauma above the clavicles, post-traumatic vomiting and headache. Patients on MTBI (5.4%) were found to be more associated with ICH than those with mHI (0.0%, p = 0.002). also when the need for neurosurgery or death within 30 days were considered. Patients on DOACs with mHI have a lower risk of presenting with post-traumatic ICH than patients with MTBI. Furthermore, patients with mHI have a lower risk of death or neurosurgery than patients with MTBI, despite the presence of ICH.

Predictors of post-traumatic complication of mild brain injury in anticoagulated patients: DOACs are safer than VKAs.

Although mild traumatic brain injury (MTBI) in people on oral anticoagulant treatment (OAT) is a frequent challenge for Emergency Department (ED), strong guidelines recommendations are lacking. In the attempt to assess the safety profile of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs), we have recruited 473 patients with a MTBI on OAT (43.6% males; age 81.8 ± 8.7 years), admitted to the Pisa's University Hospital ED (Jan 2016-Oct 2018). All patients underwent a head CT scan with those with no sign of acute bleedings remaining under clinical observation for the ensuing 24 h. Fifty patients (10.6%, 95% CI: 8.1-13.7%) had immediate intracranial hemorrhage (ICH), with a prevalence of patient-important outcomes due to immediate ICH of 1.1% (95% CI 0.4-2.4%); 3 patients died (0.6%, 95% CI 0.2-1.8) and 2 required neurosurgical intervention. Immediate ICHs were more frequent in VKA-treated than in DOAC-treated patients (15.9 vs. 6.4%. RR 2.5. 95%CI 1.4-4.4. p < 0.05). Multivariate analysis identified that post-traumatic amnesia, evidence of trauma above clavicles, high blood glucose, high blood pressure (BP) at arrival, and low prothrombin activity were predictors of immediate ICH. The prevalence of delayed ICH was 1.0% (95%CI 0.4-2.5%) without differences between DOACs and VKAs. Despite ICH being a frequent complication of MTBI in patients on OAT, immediate and delayed patient-important outcomes are rare. DOACs have a better safety profile than VKAs. Simple clinical parameters such as blood pressure at arrival or blood glucose might provide useful predictors of immediate ICH.Trial registration number: 11924_CIPRIANO. Local ethics committee approval number 33096.