Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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September 03, 2020 | 314 patients were included; 129 patients taking rivaroxaban, 182 patients taking apixaban, and four patients taking dabigatran. | Retrospective single-centre observational study | Based on the results of this study, patients who sustain a blunt head injury while taking only DOACs; that is, without concurrent antiplatelet medication, admission, and repeat head CT may not be necessary after confirming a negative initial CT scan. | In approximately 29% of the patients, the sole indication for admission was close monitoring following head injury while taking an anticoagulant agent. The mechanism of injury for the majority of the patients was fall. Of the 314 patients, three were found to have delayed intracranial hemorrhage on the repeated head CT (0.95%). Two of these three patients were on concomitant antiplatelet medication. None of the three individuals required neurosurgical intervention. | Observational study: Potential for selection bias, relatively small sample size to make a conclusion on clinical protocol |
97 consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. | Prospective, observational single-centre study | For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. | Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). | Observational study, small sample size, 10 subjects refused the second CT scan | |
2011 Dec | 500 adult blunt trauma patients admitted to our Level I trauma center from January 2006 to August 2009 who were receiving preinjury ACAP therapy. | Single-centre retrospective cohort study | The incidence of delayed ICH in our study was 1%. However, none of the delayed findings were clinically significant. Among patients on ACAP therapy with a negative CT1 and a normal or unchanged neurologic examination, a routine CT2 is unnecessary. We recommend a period of observation to recognize those patients with symptoms that could be due to delayed ICH. | Of these, 424 patients (85%) had a negative CT1. Warfarin alone was taken in 68%, clopidogrel alone in 24%, and other agents in 2%. Among patients with a negative CT1, CT2 was obtained in 362 patients (85%) and was negative in 358 patients (99%). Four patients (1%) with a negative CT1 had a positive (n = 3) or equivocal (n = 1) CT2. All the changes on CT2 were minor and had either resolved or stabilized on third head CT. Of the four patients with positive or equivocal CT2, none had a change in neurologic examination; however, two had symptoms that could be attributed to head injury. | Repeat CT scan was not obtained in 15% of patients |
2018 Oct 14 | 249 patients on DOACs admitted to two Level I Trauma Centers between 2014 and 2017 were reviewed. Only patients with a negative admission CT brain were included. | Observational multi-centre study | For patients at risk for a TBI who are on DOACs, repeat cross-sectional imaging of the brain when the initial imaging is negative is not necessary. A period of clinical observation may be warranted. | The median age was 81 years with 82% undergoing a repeat CT. Three patients developed a delayed ICH (1.2%). One developed an ICH after receiving tissue plasminogen activator for a cerebrovascular accident after two negative CTs. Excluding this patient, the incidence dropped to 0.8%. None required neurosurgical intervention. | |
2023 Nov 21 | 450 patients taking oral anticoagulants who experience minor head injury with a negative first CT scan who underwent a second CT scan | Single-cohort, prospective, observational study | In our prospective study no clinical factors emerged as predictors of poor clinical outcomes and dICI. So, even if we confirmed a low rate of adverse outcomes, the best management of these patients in ED remains not so clear and future trials are needed. | The primary outcome was the occurrence of MHI-related death or re-admission to ED at day +30. The secondary outcome was the rate of delayed ICI (dICI), defined as second positive CT scan after a first negative CT scan. The rate of the primary outcome was 4%. The rate of the secondary outcome was 4.7%. | Observational study: potential for selection bias; no time frame determined for secondary outcome (delayed ICH) |