MaltSci 麦伴科研

Appearance

Curated Papers > Recent high-impact research on "brain-computer interfaces" (IF≥30, last 5 years)

Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. ​

Literature Information ​

DOI10.1056/NEJMoa2308440
PMID38598795
JournalThe New England journal of medicine
Impact Factor78.5
JCR QuartileQ1
Publication Year2024
Times Cited104
Keywordsearly minimally invasive surgery, intracerebral hemorrhage, functional outcomes, randomized trial, medical management
Literature TypeComparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
ISSN0028-4793
Pages1277-1289
Issue390(14)
AuthorsGustavo Pradilla, Jonathan J Ratcliff, Alex J Hall, Benjamin R Saville, Jason W Allen, Giorgio Paulon, Anna McGlothlin, Roger J Lewis, Mark Fitzgerald, Angela F Caveney, Xiao T Li, Mark Bain, Joao Gomes, Brain Jankowitz, Georgios Zenonos, Bradley J Molyneaux, Jason Davies, Adnan Siddiqui, Michael R Chicoine, Salah G Keyrouz, Jonathan A Grossberg, Mitesh V Shah, Ranjeet Singh, Bradley N Bohnstedt, Michael Frankel, David W Wright, Daniel L Barrow

TL;DR ​

This multicenter randomized trial investigated the impact of early minimally invasive surgical evacuation of acute intracerebral hemorrhages compared to medical management, revealing that surgery significantly improved functional outcomes at 180 days, particularly in patients with lobar hemorrhages. The findings suggest that timely surgical intervention may enhance recovery and reduce mortality rates in this patient population, highlighting the potential benefits of surgical approaches in managing intracerebral hemorrhages.

Search for more papers on MaltSci.com ​

early minimally invasive surgery · intracerebral hemorrhage · functional outcomes · randomized trial · medical management

Abstract ​

BACKGROUND Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known.

METHODS In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment.

RESULTS A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration.

CONCLUSIONS Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).

MaltSci.com AI Research Service ​

Intelligent ReadingAnswer any question about the paper and explain complex charts and formulas
Locate StatementsFind traces of a specific claim within the paper
Add to KBasePerform data extraction, report drafting, and advanced knowledge mining

Primary Questions Addressed ​

  1. What are the long-term functional outcomes for patients with different types of intracerebral hemorrhages undergoing minimally invasive surgery?
  2. How does the timing of surgical intervention influence the recovery of patients with acute intracerebral hemorrhage?
  3. What are the potential complications associated with minimally invasive surgical removal of intracerebral hemorrhage compared to medical management?
  4. How does the modified Rankin scale correlate with other measures of quality of life in patients recovering from intracerebral hemorrhage?
  5. What are the implications of the adaptation rule on patient selection and outcomes in the trial of minimally invasive surgery for intracerebral hemorrhage?

Key Findings ​

Background and Objective ​

Intracerebral hemorrhage (ICH) presents a significant clinical challenge, with traditional surgical evacuation methods yielding no clear functional benefits. This study aimed to evaluate whether early minimally invasive surgical removal of hematomas could lead to improved outcomes compared to standard medical management in patients with acute ICH.

Main Methods/Materials/Experimental Design ​

This multicenter, randomized trial included patients diagnosed with acute intracerebral hemorrhage, specifically those with lobar or anterior basal ganglia hemorrhages, with hematoma volumes between 30 to 80 ml. Participants were randomly assigned in a 1:1 ratio to either a surgery group (minimally invasive surgical removal plus guideline-based medical management) or a control group (guideline-based medical management alone) within 24 hours of being last known well.

Key Methodological Aspects: ​

  • Primary Efficacy Endpoint: Mean score on the utility-weighted modified Rankin scale (mRS) at 180 days (scale: 0 to 1, higher scores indicate better outcomes).
  • Primary Safety Endpoint: Death within 30 days post-enrollment.
  • Adaptation Rules: Enrollment criteria were adjusted based on hemorrhage location after 175 patients, focusing solely on lobar hemorrhages.

Flowchart of Experimental Design ​

Mermaid diagram

Key Results and Findings ​

  • Enrollment: 300 patients participated; 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages.
  • Functional Outcomes:
    • Surgery group mRS score at 180 days: 0.458
    • Control group mRS score at 180 days: 0.374
    • Difference: 0.084 (95% Bayesian credible interval: 0.005 to 0.163)
    • Posterior probability of superiority for surgery: 0.981.
  • Lobar Hemorrhage Specific Results:
    • Mean difference among lobar hemorrhage patients: 0.127 (95% credible interval: 0.035 to 0.219).
    • Mean difference among anterior basal ganglia hemorrhage patients: -0.013 (95% credible interval: -0.147 to 0.116).
  • Mortality Rate:
    • Surgery group: 9.3% died within 30 days.
    • Control group: 18.0% died within 30 days.
  • Postoperative Complications: 3.3% of patients in the surgery group experienced rebleeding and neurologic deterioration.

Main Conclusions/Significance/Innovation ​

The findings suggest that minimally invasive hematoma evacuation within 24 hours of acute intracerebral hemorrhage leads to better functional outcomes at 180 days compared to standard medical management, particularly in patients with lobar hemorrhages. This study provides evidence supporting early surgical intervention in specific cases of ICH, potentially shifting clinical practice toward more proactive management strategies.

Research Limitations and Future Directions ​

  • Limitations: The trial's adaptation rule limited the diversity of hemorrhage types analyzed post-enrollment, potentially affecting the generalizability of results. The study was also confined to a specific volume range of hematomas.
  • Future Directions: Further research should explore the long-term outcomes of surgical intervention across different hemorrhage types and volumes, as well as the optimization of surgical techniques to minimize complications. Additionally, larger-scale trials could help validate these findings in broader populations.

Literatures Citing This Work ​

  1. Blood Pressure Management in Intracerebral Haemorrhage: when, how much, and for how long? - Chloe A Mutimer;Nawaf Yassi;Teddy Y Wu - Current neurology and neuroscience reports (2024)
  2. Neuro-imaging in intracerebral hemorrhage: updates and knowledge gaps. - Mary Penckofer;Khuram S Kazmi;Jesse Thon;Daniel A Tonetti;Casey Ries;Swarna Rajagopalan - Frontiers in neuroscience (2024)
  3. Ultrasonic cerebrospinal fluid clearance improves outcomes in hemorrhagic brain injury models. - Matine M Azadian;Nicholas Macedo;Brenda J Yu;Ryann M Fame;Raag D Airan - bioRxiv : the preprint server for biology (2024)
  4. Neuroendoscopic Parafascicular Evacuation of Spontaneous Intracerebral Hemorrhage (NESICH Technique): A Multicenter Technical Experience with Preliminary Findings. - Long Wang;Xiaodong Li;Zhongyong Deng;Qiang Cai;Pan Lei;Hui Xu;Sheng Zhu;Tengyuan Zhou;Ran Luo;Chao Zhang;Yi Yin;Shuixian Zhang;Na Wu;Hua Feng;Rong Hu - Neurology and therapy (2024)
  5. Formation of Multinucleated Giant Cells after Experimental Intracerebral Hemorrhage: Characteristics and Role of Complement C3. - Xiongjie Fu;Ming Wang;Yingfeng Wan;Ya Hua;Richard F Keep;Guohua Xi - Biomedicines (2024)
  6. Parallel activation of helicopter and ground transportation after dispatcher identification of suspected anterior large vessel occlusion stroke in rural areas: a proof-of-concept case with modeling from the LESTOR trial. - Max Henningsen;Matthias L Herrmann;Simone Meier;Ulrike Bergmann;Hans-Jörg Busch;Christian A Taschner;Jochen Brich - Scandinavian journal of trauma, resuscitation and emergency medicine (2024)
  7. Code-ICH: A New Paradigm for Emergency Intervention. - Aleksandra Yakhkind;Wenzheng Yu;Qi Li;Joshua N Goldstein;Stephan A Mayer - Current neurology and neuroscience reports (2024)
  8. The clinical potential of radiomics to predict hematoma expansion in spontaneous intracerebral hemorrhage: a narrative review. - Samuel A Tenhoeve;Matthew C Findlay;Kyril L Cole;Diwas Gautam;Jayson R Nelson;Julian Brown;Cody J Orton;Michael T Bounajem;Michael G Brandel;William T Couldwell;Robert C Rennert - Frontiers in neurology (2024)
  9. A Small Step Toward Rational Characterization of Intracerebral Hemorrhage Phenotypes. - Craig A Williamson - Neurocritical care (2025)
  10. Hyper-Acute Stroke Systems of Care and Workflow. - Timothy J Kleinig;Patrick McMullan;Geoffrey C Cloud;Prof Christopher Bladin;Anna Ranta - Current neurology and neuroscience reports (2024)

... (94 more literatures)

© 2025 MaltSci - We reshape scientific research with AI technology