Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)

Обзор

Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.

Подробное описание

Chronic subdural hematoma (cSDH) is a collection of fluid and blood breakdown products that evolves over weeks to months in the subdural space. This condition is more common among people older than 65 years and has been associated with increased use of antithrombotic therapy among this population. The World population is rapidly aging; thus, the investigators expect the number of patients with cSDH will increase. The United Nations World Social Report places Puerto Rico in the 7th place of countries with the largest share of people aged 65 years or over. This pathology burdens healthcare systems; therefore, assessing the feasibility of treatment modalities for cSDH that are less invasive, have lower procedural risks, and have lower recurrence rates that require additional surgical intervention is essential.

The standard of care for symptomatic cSDH is the surgical evacuation (SE) of the hematoma, with recurrence rates between 10-30% and surgical rescue indicated for most of these cases. Evacuation of the hematoma effectively relieves its mass effect but does not change the underlying pathophysiologic mechanism. In recent years, embolization of the middle meningeal artery (eMMA) has been shown to decrease the recurrence of chronic subdural hematoma and the need for revision burr hole or craniotomy. The PREMMA trial aims to compare embolization of the middle meningeal artery as stand-alone treatment for chronic subdural hematoma versus the standard of care, surgical evacuation.

Вмешательства

• Процедура Embolization of the middle meningeal artery
  Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.
• Процедура Surgical Evacuation via burr hole or craniotomy
  The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.

Первичные конечные точки

• Reoperation [Срок оценки: 3 months, 6 months, and 12 months]

Вторичные конечные точки (11)

• Modified Rankin Scale (mRS) [Срок оценки: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months]
• Glasgow Coma Scale (GCS) [Срок оценки: Pre-operative, 24 hours, 2 weeks]
• Visual Analog Scale (VAS) [Срок оценки: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months]
• Quality of life (EQ-5D-5L) [Срок оценки: Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months]
• Radiological outcomes [Срок оценки: Pre-operative, 24 hours, 3 months, 6 months, 12 months]
• Technical success of embolization of the middle meningeal artery (eMMA) [Срок оценки: 24 hours]
• Procedure-related complications [Срок оценки: 24 hours, 2 weeks, 1.5 months, 3 months]
• Adverse events [Срок оценки: 24 hours, 2 weeks, 1.5 months, 3 months]
• Post-operative morbidity [Срок оценки: 24 hours, 2 weeks, 1.5 months, 3 months]
• Mortality [Срок оценки: 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months]
• Length of stay [Срок оценки: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days]

Критерии участия

Критерии включения

• Age ≥ 21
• Speak and understand Spanish or English
• Resident of Puerto Rico
• Glasgow coma scale ≥ 14/15
• Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
• Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
• No previous surgical or endovascular treatment for symptomatic cSDH
• Signed informed consent for participation in the study by the patient or legally authorized representative

Критерии исключения

• Acute subdural hematoma
• Focal, non-hemispheric localization of cSDH
• Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
• Imaging evidence of skull fracture over the subdural hematoma
• Presence of any cerebrospinal fluid (CSF) shunt
• Imaging evidence of midline shift ≥ 10 mm
• Imaging evidence of basal cistern effacement
• Imaging evidence of dilatation of lateral ventricles
• Imaging evidence of uncal herniation
• Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
• Contraindications for angiography (i.e., complex anatomy or kidney failure)
• Comorbidity making follow-up impossible
• Pregnancy
• Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure
• Absence of medical insurance

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Ropper AH. Beneath a Tough Mother (Dura Mater) - Chronic Subdural Hematoma. N Engl J Med. 2020 Dec 31;383(27):2678-2680. doi: 10.1056/NEJMe2031257. Epub 2020 Dec 16. No abstract available. PMID 33326714
• Jung YG, Jung NY, Kim E. Independent predictors for recurrence of chronic subdural hematoma. J Korean Neurosurg Soc. 2015 Apr;57(4):266-70. doi: 10.3340/jkns.2015.57.4.266. Epub 2015 Apr 24. No abstract available. PMID 25932293
• Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y. PMID 28558815
• Moshayedi P, Liebeskind DS. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design. Front Neurol. 2020 Aug 27;11:923. doi: 10.3389/fneur.2020.00923. eCollection 2020. PMID 32973670
• Henry J, Amoo M, Kissner M, Deane T, Zilani G, Crockett MT, Javadpour M. Management of Chronic Subdural Hematoma: A Systematic Review and Component Network Meta-analysis of 455 Studies With 103 645 Cases. Neurosurgery. 2022 Dec 1;91(6):842-855. doi: 10.1227/neu.0000000000002144. Epub 2022 Sep 28. PMID 36170165
• Dudoit T, Labeyrie PE, Deryckere S, Emery E, Gaberel T. Is systematic post-operative CT scan indicated after chronic subdural hematoma surgery? A case-control study. Acta Neurochir (Wien). 2016 Jul;158(7):1241-6. doi: 10.1007/s00701-016-2820-6. Epub 2016 May 5. PMID 27147520
• Chen FM, Wang K, Xu KL, Wang L, Zhan TX, Cheng F, Wang H, Chen ZB, Gao L, Yang XF. Predictors of acute intracranial hemorrhage and recurrence of chronic subdural hematoma following burr hole drainage. BMC Neurol. 2020 Mar 13;20(1):92. doi: 10.1186/s12883-020-01669-5. PMID 32169039
• Thomas PAW, Mitchell PS, Marshman LAG. Early Postoperative Morbidity After Chronic Subdural Hematoma: Predictive Usefulness of the Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity, American College of Surgeons National Surgical Quality Improvement Program, and American Society of Anesthesiologists Grade in a Prospective Cohort. World Neurosurg. 2019 Apr;124:e48 PMID 30610985

Идентификаторы

NCT: NCT06466733 · 2305109135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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