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

Chronic Subdural Hematoma Clinical Trial

— PREMMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466733
• Other study ID #: 2305109135
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: July 2031

Study information

• Verified date: June 2024
• Source: University of Puerto Rico
• Contact: Maria M Garcia Perez
• Phone: 939-417-4432
• Email: dra.garcia.neurosx[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 658
• Est. completion date: July 2031
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juan M. Ramos Acevedo

References & Publications (34)

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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. — View Citation

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. — View Citation

Enriquez-Marulanda A, Gomez-Paz S, Salem MM, Mallick A, Motiei-Langroudi R, Arle JE, Stippler M, Papavassiliou E, Alterman RL, Ogilvy CS, Moore JM, Thomas AJ. Middle Meningeal Artery Embolization Versus Conventional Treatment of Chronic Subdural Hematomas. Neurosurgery. 2021 Aug 16;89(3):486-495. doi: 10.1093/neuros/nyab192. — View Citation

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. — View Citation

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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. — View Citation

Joyce E, Bounajem MT, Scoville J, Thomas AJ, Ogilvy CS, Riina HA, Tanweer O, Levy EI, Spiotta AM, Gross BA, Jankowitz BT, Cawley CM, Khalessi AA, Pandey AS, Ringer AJ, Hanel R, Ortiz RA, Langer D, Levitt MR, Binning M, Taussky P, Kan P, Grandhi R. Middle meningeal artery embolization treatment of nonacute subdural hematomas in the elderly: a multiinstitutional experience of 151 cases. Neurosurg Focus. 2020 Oct;49(4):E5. doi: 10.3171/2020.7.FOCUS20518. — View Citation

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. — View Citation

Kan P, Maragkos GA, Srivatsan A, Srinivasan V, Johnson J, Burkhardt JK, Robinson TM, Salem MM, Chen S, Riina HA, Tanweer O, Levy EI, Spiotta AM, Kasab SA, Lena J, Gross BA, Cherian J, Cawley CM, Howard BM, Khalessi AA, Pandey AS, Ringer AJ, Hanel R, Ortiz RA, Langer D, Kelly CM, Jankowitz BT, Ogilvy CS, Moore JM, Levitt MR, Binning M, Grandhi R, Siddiq F, Thomas AJ. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: A Multi-Center Experience of 154 Consecutive Embolizations. Neurosurgery. 2021 Jan 13;88(2):268-277. doi: 10.1093/neuros/nyaa379. — View Citation

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Ku JC, Dmytriw AA, Essibayi MA, Banihashemi MA, Vranic JE, Ghozy S, Altschul D, Regenhardt RW, Stapleton CJ, Yang VXD, Patel AB. Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. AJNR Am J Neuroradiol. 2023 Mar;44(3):297-302. doi: 10.3174/ajnr.A7796. Epub 2023 Feb 16. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Number of patients requiring reoperation due to recurrent chronic subdural hematoma.	3 months, 6 months, and 12 months
Secondary	Modified Rankin Scale (mRS)	The modified Rankin Scale (mRS) will assess neurological disability. The scale comprises seven levels, from 0 to 6, with higher scores indicating greater disability, and 6 indicating death.	Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
Secondary	Glasgow Coma Scale (GCS)	The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented).	Pre-operative, 24 hours, 2 weeks
Secondary	Visual Analog Scale (VAS)	The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain."	Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Secondary	Quality of life (EQ-5D-5L)	Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale.	Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Secondary	Radiological outcomes	Will be measured by routine computed tomography compared with pre-operative images.	Pre-operative, 24 hours, 3 months, 6 months, 12 months
Secondary	Technical success of embolization of the middle meningeal artery (eMMA)	The rate of unsuccessful eMMA due to technical failure or anatomical issues will be recorded.	24 hours
Secondary	Procedure-related complications	Any life-threatening event from enrollment to discharge will be recorded.	24 hours, 2 weeks, 1.5 months, 3 months
Secondary	Adverse events	Any unintentional injury or complication involving a prolonged stay, disability at discharge, or death caused by healthcare management, not the underlying disease, will be recorded.	24 hours, 2 weeks, 1.5 months, 3 months
Secondary	Post-operative morbidity	All surgical and/or medical complications that occur.	24 hours, 2 weeks, 1.5 months, 3 months
Secondary	Mortality	The number of participants among the total number of deaths.	24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
Secondary	Length of stay	The patient's hospitalization period.	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