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Last update 08 May 2025

Brain Stem Hemorrhage, Traumatic

Last update 08 May 2025

Basic Info

Synonyms

Brain Stem Hematoma, Traumatic, Brain Stem Hemorrhage, Post Traumatic, Brain Stem Hemorrhage, Post-Traumatic

+ [41]

Introduction

Bleeding into structures of BRAIN STEM, including the MIDBRAIN; PONS; or MEDULLA OBLONGATA, as the result of CRANIOCEREBRAL TRAUMA. DIFFUSE AXONAL INJURY is commonly associated. Clinical manifestations may include OCULAR MOTILITY DISORDERS; ATAXIA; PARALYSIS; PERSISTENT VEGETATIVE STATE; and COMA.

Clinical Trials associated with Brain Stem Hemorrhage, Traumatic

NCT06459427

/ Not yet recruitingNot ApplicableIIT

Research on Minimally Invasive Surgical Strategies for Brainstem Hemorrhage Assisted by Robotics

The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are:
Establish a multi-center clinical database for brainstem hemorrhage.
Clinically observe and evaluate the intervention effects of robot-assisted stereotactic puncture on brainstem hemorrhage, compare it with the traditional conservative treatment control group, and investigate its efficacy and impact on patient survival, motor evoked potentials, and the degree of neurological deficits.
Optimize the Artificial Intelligence (AI) algorithm-based robotic surgical assistance system, and explore the prediction of preoperative brainstem hematoma stability and hematoma path planning.
Participants in the experimental group will:
Undergo robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture
Receive conservative non-surgical treatment.
If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.

Start Date01 Jul 2025

Sponsor / Collaborator

China-Japan Friendship Hospital

ChiCTR2500101539

/ RecruitingNot ApplicableIIT

Research on the Application of Early External Diaphragm Pacing in the Withdrawal of Mechanical Ventilation for Post - operative Brainstem Hemorrhage Patients

Start Date12 Feb 2025

Sponsor / Collaborator-

ChiCTR2300077330

/ RecruitingEarly Phase 1IIT

Prediction of brain stem hemorrhage prognosis by machine learning modeling

Start Date02 Sep 2022

Sponsor / Collaborator-

100 Clinical Results associated with Brain Stem Hemorrhage, Traumatic

100 Translational Medicine associated with Brain Stem Hemorrhage, Traumatic

0 Patents (Medical) associated with Brain Stem Hemorrhage, Traumatic

269

Literatures (Medical) associated with Brain Stem Hemorrhage, Traumatic

12 Feb 2025·Zhonghua wai ke za zhi [Chinese journal of surgery]

[Neuro-electrophysiological characteristics of patients with primary brainstem hemorrhage].

Article

Author: Liu, J F ; Zhou, L ; Chen, X ; Wang, J

Objective: To investigate the neuro-electrophysiological characteristics of patients with primary brain stem hemorrhage (PBSH). Methods: This is a retrospective case series study. The clinical data of 17 PBSH patients with Glasgow Coma Score (GCS) 3 to 8 points who were admitted to the Department of Neurosurgery, Xiangya Hospital of Central South University from January 2022 to December 2023 were retrospectively analyzed. There were 14 males and 3 females, with an age(M (IQR)) of 46.0(14.0) years (range: 18.0 to 70.0 years).All patients underwent electro-physiological monitoring within 28 days after the onset of the disease. According to Glasgow outcome scale(GOS) 6 months after onset, PBSH patients were divided into two groups: unregained consciousness group with (GOS 1 to 2 points, 13 cases) and regained consciousness group (GOS 3 to 5 points, 4 cases). The neuro-electrophysiological indicators involved in this study included short latency somosensory evoked potential (SLSEP) component N20, brainstem auditory evoked potential (BAEP), electroencephalogram (EEG) background activity, EEG reactivity (EEG-R), EEG sleep structure waves, absolute amplitude of N1 at electrode Fz (FzN1A) and Cz (CzN1A), respectively, absolute amplitude of mismatch negativity at electrode Fz (FzMMNA) and Cz (CzMMNA), respectively. Then, the Fisher exact probability test and Mann Whitney U test were used for counting data and measurement data, respectively, to analyze the differences of neuro-electrophysiological indicators between the two groups. Results: The EEG background activity of 17 PBSH patients was mainly α-mode, α-θ mode and θ mode. Four patients with α-mode, 3 of whom regained consciousness (all with EEG-R). There were 3 patients with α-θ pattern. And 5 patients with θ pattern, 2 of whom died. Five patients with background EEG activity of delta pattern had poor prognosis, of which 4 patients died and 1 patient survived but did not regain consciousness 6 months after onset. SLSEP component N20 were absent bilaterally in 12 cases and BAEP in 5 cases. FzN1A and CzN1A were not extracted in 4 cases, and FzMMNA and CzMMNA were not extracted in 6 cases. The study showed that BAEP, EEG background activity, EEG-R, FzN1A, CzN1A, FzMMNA and CzMMNA were different between the two groups (all P<0.05), while there was no difference between N20 and EEG sleep structure (all P>0.05). Conclusion: The neuro-electrophysiological indicators including BAEP, EEG background activity, EEG-R, FzN1A, CzN1A, FzMMNA, and CzMMNA may be related to whether PBSH patients can regain consciousness 6 months after onset, and it is best to combine multiple indicators for comprehensive analysis in clinical practice.

01 Feb 2025·World Neurosurgery

3-Dimensional Technology-Assisted Minimally Invasive Surgery for the Treatment of Primary Brainstem Hemorrhage: A Prospective Cohort Study

Article

Author: Han, Qiu ; Tong, Qiang ; Tian, Xiangyang ; Chen, Quan ; Zhu, Xiaofeng ; Wei, Ming ; Yang, Xiu

BACKGROUNDThe objective of this study was to assess the therapeutic efficacy of minimally invasive puncture and drainage (MIPD) facilitated by a 3-dimensional (3D)-printed guide plate in the management of primary brainstem hemorrhage (PBH).METHODSThis single-center, prospective cohort study enrolled 30 PBH patients who underwent MIPD guided by 3D printing technology and 30 PBH patients who received conservative treatment, serving as the control cohort. The primary endpoint was the proportion of patients achieving modified Rankin Scale scores of 1 and 2 at 30 days postdischarge. Secondary endpoints included hematoma volume at admission and post-treatment, incidence of hospital-acquired pneumonia (HAP) and/or rebleeding, in-hospital mortality rate, and length of hospital stay.RESULTSThe treatment cohort demonstrated a significantly higher proportion of patients with modified Rankin Scale scores of 1 and 2 at 30 days postdischarge compared to the control cohort. Conversely, the treatment cohort exhibited significantly lower postoperative hematoma volumes, National Institutes of Health Stroke Scale scores, HAP incidence, in-hospital mortality, and hospital stay duration than the control cohort. However, no significant difference in rebleeding incidence was observed between the 2 cohorts.CONCLUSIONSMIPD guided by 3D printing technology is more effective than conservative treatment in PBH cases without extensive hemorrhage. This approach can alleviate hematoma pressure earlier, mitigate neurological deficits, reduce HAP incidence, shorten hospital stay, and decrease mortality and disability rates associated with PBH.

01 Jan 2025·The Lancet

Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study

Article

Author: Mody, Kalgi ; Dutcus, Corina ; Siegel, Abby B ; Llovet, Josep M ; Kim, Ji Hoon ; Lin, Hailan ; Ghobrial, R Mark ; Madoff, David C ; Ikeda, Masafumi ; Vogel, Arndt ; Ren, Zhenggang ; Peng, Xiang ; Han, Guohong ; Zhao, Haitao ; El-Khoueiry, Anthony B ; Li, Chuan ; Ogasawara, Sadahisa ; Kawaoka, Tomokazu ; Zheng, Jinfang ; Guo, Yabing ; Gerolami, René ; Finn, Richard S ; Kumada, Hiromitsu ; Kudo, Masatoshi ; Dubrovsky, Leonid

BACKGROUNDTransarterial chemoembolisation (TACE) is standard care for unresectable, non-metastatic hepatocellular carcinoma. We aimed to evaluate the addition of lenvatinib and pembrolizumab to TACE versus dual placebo plus TACE in patients with unresectable, non-metastatic hepatocellular carcinoma.METHODSIn this multicentre, randomised, double-blind, phase 3 study (LEAP-012), patients were recruited from 137 global sites in 33 countries or regions. Eligible patients were age 18 years or older with unresectable, non-metastatic hepatocellular carcinoma not amenable to curative treatment, but with tumours amenable to TACE, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and Child-Pugh class A disease. Eligible participants were randomly assigned (1:1), stratified by study site, α-fetoprotein level, ECOG performance status, albumin-bilirubin grade, and tumour burden, by a central interactive response system, to receive TACE and either oral lenvatinib (bodyweight ≥60 kg: 12 mg; bodyweight <60 kg: 8 mg; once daily) plus intravenous pembrolizumab (400 mg once every 6 weeks for up to 2 years) or matched dual placebo (oral and intravenous). Primary endpoints were progression-free survival (threshold one-sided p=0·025), per Response Evaluation Criteria in Solid Tumours version 1.1 (modified for the current study to allow for up to five target tumours in the liver and requiring new intrahepatic tumours to meet LI-RADS 5 criteria to be considered progressive disease) by blinded independent central review, and overall survival (threshold one-sided p=0·0012) in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Safety was assessed in the as-treated population (ie, all participants who were randomly assigned and received at least one dose of any study treatment). Here, we report results from the first interim analysis (final analysis for progression-free survival). This study is registered with ClinicalTrials.gov, NCT04246177, and is active but not recruiting.FINDINGSBetween May 22, 2020, and Jan 11, 2023, 847 patients were screened, of whom 480 (57%) were enrolled and randomly assigned to receive TACE plus lenvatinib plus pembrolizumab (n=237) or TACE plus dual placebo (n=243; ITT population). Median age was 66 years (IQR 58-73), 82 (17%) of 480 participants were female, 398 (83%) were male, 98 (20%) were White, 347 (72%) were Asian, four (1%) were Black or African American, and five (1%) were American Indian or Alaska Native. Median follow-up as of data cutoff (Jan 30, 2024) was 25·6 months (IQR 19·5-32·4). Median progression-free survival was 14·6 months (95% CI 12·6-16·7; 132 events [20 deaths and 112 progressions]) with lenvatinib plus pembrolizumab and 10·0 months (8·1-12·2; 154 events [eight deaths and 146 progressions]) with placebo (hazard ratio [HR] 0·66 [95% CI 0·51-0·84]; one-sided p=0·0002). 69 (29%) of 237 in the lenvatinib plus pembrolizumab group and 82 (34%) of 243 from the placebo group died, with a 24-month overall survival rate of 75% (95% CI 68-80) in the lenvatinib plus pembrolizumab group and 69% (62-74) in the placebo group (HR 0·80 [95% CI 0·57-1·11]; one-sided p=0·087). Grade 3 or worse treatment-related adverse events occurred in 169 (71%) of 237 participants in the lenvatinib plus pembrolizumab group and in 76 (32%) of 241 in the placebo group, the most common of which were hypertension (57 [24%] vs 18 [7%]) and platelet count decreased (27 [11%] vs 15 [6%]). Deaths due to treatment-related adverse events occurred in four (2%) participants in the lenvatinib plus pembrolizumab group (n=1 each due to hepatic failure, gastrointestinal haemorrhage, myositis, and immune-mediated hepatitis) and one (<1%) in the placebo group (due to brain stem haemorrhage).INTERPRETATIONTACE plus lenvatinib plus pembrolizumab showed significant, clinically meaningful improvement in progression-free survival in patients with unresectable, non-metastatic hepatocellular carcinoma compared with TACE plus placebo. The numerical improvement in overall survival is encouraging, but longer follow-up is necessary.FUNDINGMerck Sharp & Dohme, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA, and Eisai, Nutley, NJ, USA.

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