Browsing by Author "Goyal, Mayank"

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    Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol
    (2023-09-14) Zuo, Qiao; Ni, Wei; Yang, Pengfei; Gu, Yuxiang; Yu, Ying; Yang, Heng; Majoie, Charles B. L. M.; Goyal, Mayank; Liu, Jianmin; Mao, Ying
    Abstract Background The conventional treatments for non-acute subdural hematoma (SDH) are facing the challenge of high hematoma recurrence and progression. A novel treatment of middle meningeal artery (MMA) embolization showed the potential role in decreasing the recurrence and progression rate of SDH compared to conventional treatments in multiple cohort studies. A randomized controlled trial is warranted to determine the effectiveness and safety of MMA embolization for non-acute hematoma and whether MMA embolization is superior to conventional treatments to lower the symptomatic recurrence and progression rate of non-acute SDH. Methods This is an investigator-initiated, multi-center, prospective, open-label parallel group trial with blinded outcome assessment (PROBE design) assessing superiority of MMA embolization compared to conventional treatments. A total of 722 patients are planned to be randomized 1:1 to receive MMA embolization (intervention) or conventional treatments (control). The primary outcome is the symptomatic SDH recurrence/progression rate within 90 ± 14 days post-randomization. Discussion This trial will clarify whether MMA embolization could reduce the recurrence or progression rate of symptomatic non-acute SDH compared to conventional treatment. Trial registration ClinicalTrials.gov. Identifier: NCT04700345, Registered on 7 January 2021.
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    Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial
    (2017-11-02) Sajobi, Tolulope T; Singh, Gurbakhshash; Lowerison, Mark W; Engbers, Jordan; Menon, Bijoy K; Demchuk, Andrew M; Goyal, Mayank; Hill, Michael D
    Abstract Background We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the “Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times” (ESCAPE) trial. Methods The ESCAPE trial is a prospective, multicenter, randomized clinical trial that enrolled subjects with the following main inclusion criteria: less than 12 h from symptom onset, age 18 years or older, baseline NIHSS score > 5, ASPECTS score > 5 and computed tomography angiography (CTA) evidence of carotid T/L or M1-segment middle cerebral artery (MCA) occlusion, and at least moderate collaterals by CTA. Patients were randomized using a real-time, dynamic, Internet-based, minimal sufficient balance randomization method that balanced the study arms with respect to baseline covariates including age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS score and treatment with intravenously administered alteplase. Results Permutation-based tests of group differences confirmed group balance across several baseline covariates including sex (p = 1.00), baseline NIHSS score (p = 0.95), site of arterial occlusion (p = 1.00), baseline ASPECTS score (p = 0.28), treatment with intravenously administered alteplase (p = 0.31), and age (p = 0.67). Conclusion Results from the ESCAPE trial demonstrate the feasibility and the benefit of this covariate adaptive randomization scheme in small-sample trials and for data monitoring endeavors. Trial registration ESCAPE trial – NCT01778335 – at www.clinicaltrials.gov . Registered on 29 January 2013.
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    Predicting the Risk of Intracerebral Haemorrhage in Patients with Acute Ischemic Stroke Receiving IV-alteplase with or Without Endovascular Thrombectomy
    (2016) Batchelor, Connor; Menon, Bijoy K.; Demchuk, Andrew M.; Goyal, Mayank; Lee, Ting-Yim; Sajobi, Tolulope
    Intracerebral Haemorrhage (ICH) is a devastating complication of acute ischemic stroke (AIS) treatment with no known effective management protocols. The need to identify patients at risk of developing this condition is becoming increasingly recognized among the stroke community. Computed tomography perfusion (CTP) is a powerful diagnostic imaging tool that measures blood flow in the brain. This tool can also be used to provide information regarding the integrity of the blood-brain barrier (BBB). Severe brain ischemia and consequent disruption of the BBB are probable mechanisms for why ICH occurs after AIS treatment. The goal of my research is to investigate the potential role of CTP primarily and other imaging and clinical parameters in predicting ICH secondary to AIS treatment in patients.