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

NCT06466733 | Not Yet Recruiting DMC

• 1 other identifier: 2305109135
• Study Type: interventional
• Target: 658
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Embolization of the middle meningeal artery; Surgical evacuation; Hemorrhage; Intracranial hemorrhage; Cerebrovascular disease; Chronic disease

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Number of patients requiring reoperation due to recurrent chronic subdural hematoma.

  3 months, 6 months, and 12 months

Secondary Outcomes (11)

• Modified Rankin Scale (mRS)

  Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months

• Glasgow Coma Scale (GCS)

  Pre-operative, 24 hours, 2 weeks

• Visual Analog Scale (VAS)

  Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months

• Quality of life (EQ-5D-5L)

  Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months

• Radiological outcomes

  Pre-operative, 24 hours, 3 months, 6 months, 12 months

Study Arms (2)

Endovascular Embolization

EXPERIMENTAL

Embolization of the middle meningeal artery

Procedure: Embolization of the middle meningeal artery

Surgical Evacuation of Hematoma

ACTIVE COMPARATOR

Burr hole or craniotomy

Procedure: Surgical Evacuation via burr hole or craniotomy

Interventions

Embolization of the middle meningeal artery PROCEDURE

Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.

Endovascular Embolization

Surgical Evacuation via burr hole or craniotomy PROCEDURE

The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.

Also known as: Burr hole, Craniotomy

Surgical Evacuation of Hematoma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan M. Ramos Acevedo: lead

Related Publications (34)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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:e489-e497. doi: 10.1016/j.wneu.2018.12.119. Epub 2019 Jan 3.

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• Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.

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• Nouri A, Gondar R, Schaller K, Meling T. Chronic Subdural Hematoma (cSDH): A review of the current state of the art. Brain Spine. 2021 Nov 2;1:100300. doi: 10.1016/j.bas.2021.100300. eCollection 2021.

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• Desir LL, Narayan V, Ellis J, Gordon D, Langer D, Ortiz R, Serulle Y. Middle Meningeal Artery Embolization in the Management of Chronic Subdural Hematoma: a Comprehensive Review of Current Literature. Curr Neurol Neurosci Rep. 2023 Apr;23(4):109-119. doi: 10.1007/s11910-023-01262-6. Epub 2023 Apr 11.

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• Miah IP, Tank Y, Rosendaal FR, Peul WC, Dammers R, Lingsma HF, den Hertog HM, Jellema K, van der Gaag NA; Dutch Chronic Subdural Hematoma Research Group. Radiological prognostic factors of chronic subdural hematoma recurrence: a systematic review and meta-analysis. Neuroradiology. 2021 Jan;63(1):27-40. doi: 10.1007/s00234-020-02558-x. Epub 2020 Oct 22.

  PMID: 33094383 BACKGROUND

• Rauhala M, Helen P, Huhtala H, Heikkila P, Iverson GL, Niskakangas T, Ohman J, Luoto TM. Chronic subdural hematoma-incidence, complications, and financial impact. Acta Neurochir (Wien). 2020 Sep;162(9):2033-2043. doi: 10.1007/s00701-020-04398-3. Epub 2020 Jun 10.

  PMID: 32524244 BACKGROUND

• Almenawer SA, Farrokhyar F, Hong C, Alhazzani W, Manoranjan B, Yarascavitch B, Arjmand P, Baronia B, Reddy K, Murty N, Singh S. Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients. Ann Surg. 2014 Mar;259(3):449-57. doi: 10.1097/SLA.0000000000000255.

  PMID: 24096761 BACKGROUND

• Ironside N, Nguyen C, Do Q, Ugiliweneza B, Chen CJ, Sieg EP, James RF, Ding D. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review and meta-analysis. J Neurointerv Surg. 2021 Oct;13(10):951-957. doi: 10.1136/neurintsurg-2021-017352. Epub 2021 Jun 30.

  PMID: 34193592 BACKGROUND

• Mignucci-Jimenez G, Matos-Cruz AJ, Abramov I, Hanalioglu S, Kovacs MS, Preul MC, Feliciano-Valls CE. Puerto Rico Recurrence Scale: Predicting chronic subdural hematoma recurrence risk after initial surgical drainage. Surg Neurol Int. 2022 Jun 3;13:230. doi: 10.25259/SNI_240_2022. eCollection 2022.

  PMID: 35855136 BACKGROUND

• Flores G, Vicenty JC, Pastrana EA. Post-operative seizures after burr hole evacuation of chronic subdural hematomas: is prophylactic anti-epileptic medication needed? Acta Neurochir (Wien). 2017 Nov;159(11):2033-2036. doi: 10.1007/s00701-017-3298-6. Epub 2017 Aug 15.

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• De Jesus O, Monserrate AE. Burr Hole Surgery for Drainage of Chronic and Subacute Subdural Hematomas: Low Recurrence Rate in a Single Surgeon Cohort. Cureus. 2021 Nov 5;13(11):e19288. doi: 10.7759/cureus.19288. eCollection 2021 Nov.

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• Altaf I, Shams S, Vohra AH. Radiolological predictors of recurrence of chronic subdural hematoma. Pak J Med Sci. 2018 Jan-Feb;34(1):194-197. doi: 10.12669/pjms.341.13735.

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• Ban SP, Hwang G, Byoun HS, Kim T, Lee SU, Bang JS, Han JH, Kim CY, Kwon OK, Oh CW. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma. Radiology. 2018 Mar;286(3):992-999. doi: 10.1148/radiol.2017170053. Epub 2017 Oct 10.

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• Desir LL, D'Amico R, Link T, Silva D, Ellis JA, Doron O, Langer DJ, Ortiz R, Serulle Y. Middle Meningeal Artery Embolization and the Treatment of a Chronic Subdural Hematoma. Cureus. 2021 Oct 18;13(10):e18868. doi: 10.7759/cureus.18868. eCollection 2021 Oct.

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MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hemorrhage; Intracranial Hemorrhages; Cerebrovascular Disorders; Chronic Disease

Interventions

Craniotomy; Trephining

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Juan M Ramos Acevedo, MD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria M Garcia Perez

CONTACT

939-417-4432; dra.garcia.neurosx@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 20, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2032
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share