Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)

Официальное название

Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial

Обзор

This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.

Подробное описание

Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually. The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage. Treatment options for SSICH consist of either the current gold standard, best medical treatment (BMT), or surgical hematoma evacuation. Neither the best medical treatment nor the established surgical mainstay (conventional craniotomy) have shown relevant improvement of survival or functional outcome rates. A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. An earlier, more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients. The primary objective of this two-armed, open-labelled, single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH. The study procedures include 6 visits in total, 4 of them during hospital stay, 2 of them as follow-up visits within the clinical routine. Each visit consists of assessing Glasgow Coma Scale (GCS), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), three visits include CT scans (before intervention, directly postoperative and during follow up) and blood sampling (before intervention, postoperative and during follow up). Three visits include assessing patient satisfaction and cognition, and two visits include patient quality of life assessments. This study was designed in collaboration with Patient and Public representatives.

Вмешательства

• Процедура Early minimally invasive image guided endoscopic hematoma evacuation
  The intervention group will first receive BMT (as defined below) upon admission and early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT. Surgery will be performed within 6-24 hours after SSICH symptom onset. Surgery will be performed in an emergency operating theatre or a hybrid operation theatre equipped with intraoperative CT (in hybrid OR), neuronavigation, and neuro-endoscopy.The position and progress of the trocar towards the hematoma cavity will
• Процедура Best medical treatment (BMT)
  The control group will receive the current gold standard treatment for SSICH according to the guidelines (BMT). This involves strict blood pressure control (SBP\<140mmHg), if needed with intravenous or intraarterial blood pressure lowering agents, reversal of anticoagulation if applicable, intensive care surveillance and nursing on a ICU or stroke unit, control of seizures as well as glucose levels as needed and neurointensive monitoring if deemed necessary

Первичные конечные точки

• Good functional outcome, measured by the modified Rankin Scale (mRS) [Срок оценки: At 6 months after treatment]

Вторичные конечные точки (10)

• Mortality rate [Срок оценки: At 6 and 12 months after intervention]
• Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire [Срок оценки: At 3 and 6 months after intervention]
• Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® ) [Срок оценки: At 3 and 6 months after intervention]
• Morbidity rate [Срок оценки: At 6 and 12 months after intervention]
• Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS) [Срок оценки: From baseline to 6 months after intervention]
• Time to intervention [Срок оценки: At baseline]
• Total time spent on the intensive care unit (ICU)/stroke unit [Срок оценки: At 7 days/discharge after intervention]
• Total time spent in intubation measured in minutes [Срок оценки: At 7 days/discharge after intervention]
• Proportion of hematoma volume reduction rate (in the intervention group only) [Срок оценки: Directly after intervention]
• Change in Patient Satisfaction Questionnaire [Срок оценки: At 3 and 6 months after intervention]

Критерии участия

Критерии включения

• Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging
• SSICH volume ≥20 mL <100 mL
• A focal neurological deficit consisting of either

• clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined)
• clinically relevant motor or sensory aphasia (≥2 points on the NIHSS)
• clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)
• decreased level of consciousness (Glasgow Coma Scale (GCS)≤13)
• Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)
• Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset
• Informed consent of patient or appropriate surrogate (for patients without competence)

Критерии исключения

• SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction
• Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)
• Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage
• Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of >1.5 which cannot be pharmacologically reverted until the planned time of evacuation
• Pregnancy
• Relevant disability prior to SSICH (mRS >2)
• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 10 центров

• Department of Neurosurgery, University Hospital Basel — Basel
• University Hospital Bern — Bern
• Hopitaux Universitare Geneve — Geneva
• Centre Hopitalier Universitaire Vaudoise — Lausanne
• Luzerner Kantonsspital — Lucerne
• Ospedale Regionale di Lugano — Lugano
• Kantonsspital St. Gallen — Sankt Gallen
• Centre Hopitalier Universitaire du Valais Romand — Sion
• … и ещё 2 центра

Публикации

• Hallenberger TJ, Guzman R, Soleman J. Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it. Acta Neurochir (Wien). 2023 Jun;165(6):1597-1602. doi: 10.1007/s00701-022-05326-3. Epub 2022 Aug 5. PMID 35930078
• Hallenberger TJ, Fischer U, Ghosh N, Kuhle J, Guzman R, Bonati LH, Soleman J. Early minimally invasive image-guided eNdoscopic evacuation of iNTracerebral hemorrhage: a phase II pilot trial. Front Neurol. 2024 Nov 19;15:1484255. doi: 10.3389/fneur.2024.1484255. eCollection 2024. PMID 39628893
• Hallenberger TJ, Fischer U, Bonati LH, Dutilh G, Mucklow R, Vogt AS, Boeni-Eckstein C, Cardia A, Schubert GA, Bijlenga P, Messerer M, Raabe A, Akeret K, Zweifel C, Kuhle J, Alfieri A, Fournier JY, Fandino J, Hostettler IC, Schneider UC, Guzman R, Soleman J. Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial. Trials. PMID 39425219

Идентификаторы

NCT: NCT05681988 · 2022-02216; ko22Guzman

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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