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In an international trial involving 450 patients with acute subdural hematoma, craniotomy (bone flap replaced) and decompressive craniectomy (bone flap left out) yielded similar disability-related outcomes at 12 months.

IntroductionSubdural haematomas (SDHs), acute or chronic, are common neurosurgical diagnoses. These problems can occur among patients requiring direct oral anticoagulation (DOAC) for atrial fibrillation. There are currently no guidelines regarding the optimal timing to resume anticoagulation for these patients after SDH. The objective of this study is to evaluate the feasibility of conducting a future large randomised controlled trial (RCT) evaluating the safety and efficacy of resuming DOACs early (ie, at 30 days) vs late (ie, at 3 months) for patients with atrial fibrillation following diagnosis of SDH.Methods and analysisThis is a pilot, open-label, multicentre RCT that will enrol adults with newly diagnosed acute or chronic SDH with or without other intracranial bleeding who were receiving therapeutic anticoagulation with a DOAC as stroke prophylaxis for atrial fibrillation. Patients will be randomly allocated to resume a DOAC at standard dosing starting either days 30+7 or days 90±14. The primary outcomes for the pilot RCT are recruitment rate, protocol adherence and patient compliance with the randomly allocated interventions. Secondary outcomes are patient functional outcomes and safety and effectiveness outcomes, which will comprise key endpoints for the future planned RCT. This pilot RCT will provide important data to inform the feasibility of conducting a future, large RCT of early versus late resumption of DOACs for atrial fibrillation stroke prophylaxis in patients newly diagnosed with SDH. The future RCT will help inform management of a commonly encountered clinical dilemma with high associated morbidity and mortality.Ethics and disseminationThis study has been approved by the research ethics board of record. It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. Informed consent will be obtained from eligible patients or substitute decision-makers. Data from this study will inform the design of future, larger RCTs.Trial registration numberNCT05472766.

Background The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH Methods In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024. Discussion The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. Trial registration Nederlands Trial Register (NTR), Trial NL9012 . ClinicalTrials.gov, Trial NCT04648436 .

ObjectiveTo estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH).DesignEconomic evaluation undertaken using health resource use and outcome data from the 12-month multicentre, pragmatic, parallel-group, randomised, Randomised Evaluation of Surgery with Craniectomy for Patients Undergoing Evacuation-ASDH trial.SettingUK secondary care.Participants248 UK patients undergoing surgery for traumatic ASDH were randomised to craniotomy (N=126) or DC (N=122).InterventionsSurgical evacuation via craniotomy (bone flap replaced) or DC (bone flap left out with a view to replace later: cranioplasty surgery).Main outcome measuresIn the base-case analysis, costs were estimated from a National Health Service and Personal Social Services perspective. Outcomes were assessed via the quality-adjusted life-years (QALY) derived from the EuroQoL 5-Dimension 5-Level questionnaire (cost-utility analysis) and the Extended Glasgow Outcome Scale (GOSE) (cost-effectiveness analysis). Multiple imputation and regression analyses were conducted to estimate the mean incremental cost and effect of craniotomy compared with DC. The most cost-effective option was selected, irrespective of the level of statistical significance as is argued by economists.ResultsIn the cost-utility analysis, the mean incremental cost of craniotomy compared with DC was estimated to be −£5520 (95% CI −£18 060 to £7020) with a mean QALY gain of 0.093 (95% CI 0.029 to 0.156). In the cost-effectiveness analysis, the mean incremental cost was estimated to be −£4536 (95% CI −£17 374 to £8301) with an OR of 1.682 (95% CI 0.995 to 2.842) for a favourable outcome on the GOSE.ConclusionsIn a UK population with traumatic ASDH, craniotomy was estimated to be cost-effective compared with DC: craniotomy was estimated to have a lower mean cost, higher mean QALY gain and higher probability of a more favourable outcome on the GOSE (though not all estimated differences between the two approaches were statistically significant).EthicsEthical approval for the trial was obtained from the North West—Haydock Research Ethics Committee in the UK on 17 July 2014 (14/NW/1076).Trial registration numberISRCTN87370545.

Anticoagulation is used to prevent thromboembolic events. It is a common practice to hold anticoagulation in the first few days following a traumatic brain injury (TBI) with intracranial hemorrhage. However, traumatic subdural hematomas (SDH) are prone to re-hemorrhage long after the trauma. Data are scarce in the literature on the best timing to resume anticoagulation following a TBI. Review of 95 consecutive patients admitted to a level 1 trauma center with a diagnosis of traumatic SDH and requiring anticoagulation. The reasons for anticoagulation, the amount of time without anticoagulation, CT characteristics, and the incidence of thromboembolic events or SDH re-hemorrhage were collected. 41.3% used anticoagulation for coronary artery disease and peripheral vascular disease, 24% for atrial fibrillation, 12% for cardiac valve replacement, and 12% for venous thromboembolic events. Anticoagulation was held a median of 67 days. For most patients (82.1%), anticoagulation was re-introduced once the SDH had completely resolved. For 17.9%, anticoagulation was restarted while the SDH had not completely resolved. One (1.1%) patient suffered from an atrial clot while anticoagulation was held. For those with residual SDH, 41.2% suffered from a SDH re-hemorrhage and 17.6% required surgery. The risk of re-hemorrhage climbed to 62.5% if the SDH remnant was large. Anticoagulation while there is a residual SDH was associated with a significant risk of re-hemorrhage. This risk should be weighed against the risk of holding anticoagulation.

Background Hypothermia is neuroprotective in some ischemia–reperfusion injuries. Ischemia–reperfusion injury may occur with traumatic subdural hematoma (SDH). This study aimed to determine whether early induction and maintenance of hypothermia in patients with acute SDH would lead to decreased ischemia–reperfusion injury and improve global neurologic outcome. Methods This international, multicenter randomized controlled trial enrolled adult patients with SDH requiring evacuation of hematoma within 6 h of injury. The intervention was controlled temperature management of hypothermia to 35 °C prior to dura opening followed by 33 °C for 48 h compared with normothermia (37 °C). Investigators randomly assigned patients at a 1:1 ratio between hypothermia and normothermia. Blinded evaluators assessed outcome using a 6-month Glasgow Outcome Scale Extended score. Investigators measured circulating glial fibrillary acidic protein and ubiquitin C-terminal hydrolase L1 levels. Results Independent statisticians performed an interim analysis of 31 patients to assess the predictive probability of success and the Data and Safety Monitoring Board recommended the early termination of the study because of futility. Thirty-two patients, 16 per arm, were analyzed. Favorable 6-month Glasgow Outcome Scale Extended outcomes were not statistically significantly different between hypothermia vs. normothermia groups (6 of 16, 38% vs. 4 of 16, 25%; odds ratio 1.8 [95% confidence interval 0.39 to ∞], p  = .35). Plasma levels of glial fibrillary acidic protein ( p  = .036), but not ubiquitin C-terminal hydrolase L1 ( p  = .26), were lower in the patients with favorable outcome compared with those with unfavorable outcome, but differences were not identified by temperature group. Adverse events were similar between groups. Conclusions This trial of hypothermia after acute SDH evacuation was terminated because of a low predictive probability of meeting the study objectives. There was no statistically significant difference in functional outcome identified between temperature groups.

Traumatic acute subdural hematomas often warrant emergency evacuation of the blood clot to avoid further cerebral compression and its sequelae. Once the subdural clot is removed, the million-dollar question in the mind of the neurosurgeon is to whether to replace the bone flap (craniotomy) or not (decompressive craniectomy). In some instances, the decision to leave the bone flap on or off is relatively straightforward, such as in older persons with atrophic brains who have a visually “relaxed” brain after clot evacuation (in whom the bone flap should be replaced) or in a patient with massively swollen brain (in whom the . . .

Background and Objective: The study’s aim is to identify a subgroup of patients who would benefit from primary decompressive craniectomy (pDC) after acute subdural hematoma (aSDH) evacuation. Materials and Methods: A retrospective analysis of 290 patients undergoing aSDH evacuation between 2016 and 2021 was conducted. Osteoplastic craniotomy (OC) was performed in 213 cases (73.4%), whereas 77 individuals underwent pDC. Preoperative characteristics, such as age, initial GCS score, hematoma thickness, midline shift, and cisternal effacement score (CES), were used to predict outcome at discharge by the Glasgow Outcome Scale (GOS). Results: Older age, lower initial GCS, and higher CES preoperatively were independently associated with lower GOS scores at discharge. Age and degree of cisternal compression remained significant predictors of GOS score in the pDC subgroup. Survivors who underwent pDC were younger in comparison to deceased individuals receiving OC (mean age 55.43 ± 14.58 vs. 72.28 ± 14.63, p < 0.001). Patients who achieved favorable outcomes after pDC were significantly younger compared to those who had poor outcomes after OC (mean age 49.20 ± 12.05 vs. 72.28 ± 14.32, p < 0.001). Conclusions: Younger patients (<55 years old) with initial GCS scores of 4–6, midline shifts of 1 to 2 cm, subdural hematoma thickness of 1 to 2.5 cm, and CES in a range of 7–12 may benefit from pDC as it could potentially improve survival and functional outcomes after aSDH evacuation.

The purpose of this study was to evaluate the optimal timing and type of pharmacological venous thromboembolism prophylaxis (VTEp) in patients with severe blunt head trauma with acute subdural hematomas (ASDH). Matched cohort study using ACS-TQIP database (2013–2016) including patients with isolated ASDH. Outcomes of matched patients receiving early prophylaxis (EP, ≤48 h) and late prophylaxis (LP, >48 h) were compared with univariable and multivariable regression analysis. In 1,660 matched cases VTE complications (3.1% vs 0.5%, p < 0.001) were more common in the LP compared to the EP group. Multivariable regression analysis identified EP as an independent protective factor for VTE complications (OR 0.169, p < 0.001) but not mortality (p = 0.260). The adjusted risk for delayed craniectomy was not associated with EP compared to LP (p = 0.095). LMWH was independently associated with a lower mortality (OR 0.480, p = 0.008) compared to UH. Early VTEp (≤48 h) does not increase the risk for craniectomies and is independently associated with fewer VTE complications in patients with isolated ASDH. LMWH was independently associated with a lower mortality compared to UH. •Timing of VTEp has no effect on mortality or delayed craniectomy in patients with acute subdural hematomas.•Early VTEp (≤48 h) is associated with less thromboembolism complications compared to late VTEp (>48 h).•LMWH is independently associated with a lower mortality compared to UH.

Background Traumatic acute subdural haematoma is a debilitating condition. Laterality intuitively influences management and outcome. However, in contrast to stroke, this research area is rarely studied. The aim is to investigate whether the hemisphere location of the ASDH influences patient outcome. Methods For this multicentre observational retrospective cohort study, patients were considered eligible when they were treated by a neurosurgeon for traumatic brain injury between 2008 and 2012, were > 16 years of age, had sustained brain injury with direct presentation to the emergency room and showed a hyperdense, crescent shaped lesion on the computed tomography scan. Patients were followed for a duration of 3-9 months post-trauma for functional outcome and 2-6 years for health-related quality of life. Main outcomes and measures included mortality, Glasgow Outcome Scale and the Quality of Life after Brain Injury score. The hypothesis was formulated after data collection. Results Of the 187 patients included, 90 had a left-sided ASDH and 97 had a right-sided haematoma. Both groups were comparable at baseline and with respect to the executed treatment. Furthermore, both groups showed no significant difference in mortality and Glasgow Outcome Scale score. Health-related quality of life, assessed 59 months (IQR 43-66) post-injury, was higher for patients with a right-sided haematoma (Quality of Life after Brain Injury score: 80 vs 61, P =  0.07). Conclusions This study suggests patients with a right-sided acute subdural haematoma have a better long-term health-related quality of life compared to patients with a left-sided acute subdural haematoma.