Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms

NCT06274580 | Not Yet Recruiting FDA Device

• 1 other identifier: 5916
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.

Conditions

Subdural Hematoma, Chronic

Keywords

subdural hematoma; chronic; embolization; middle meningeal artery

Outcome Measures

Primary Outcomes (1)

• Rate of incomplete hematoma resolution or surgical rescue

  Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief of symptoms (mRS≥3 and Markwalder scale≥2) that develope with progressive growth of the cSDH

  6 months

Secondary Outcomes (2)

• treatment complication

  30 days

• treatment successful

  periprocedural

Study Arms (2)

Embolization of the middle meningeal artery

EXPERIMENTAL

Endovascular treatment of chronic subdural hematoma

Device: embolization of the middle meningeal artery

standard of care

NO INTERVENTION

control group will managed according to the current standard of care with "wait and see" approach and best medical treatment

Interventions

embolization of the middle meningeal artery DEVICE

Embolization of the MMA is occluded with PVA particles or liquid embolizing materials

Embolization of the middle meningeal artery

Eligibility Criteria

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

You may qualify if:

• No neurological deficits (Markwalder score ≤1);
• Unilateral or bilateral cSDH;
• Subdural Hematoma width ≤ 20 mm; midline shift ≤ 7mm;
• Independent functional status with mRS score ≤ 2 prior to symptom onset;
• Likely compliance of the participant in attending follow-up examination.

You may not qualify if:

• Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma;
• Contraindications to angiography (end stage chronic renal disease, any sign of anatomical variations that could make MMA embolization unsafe, pregnancy);
• Life expectancy \< 1 year;
• Patients with any kind of ventricular derivation catheter.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Related Publications (6)

• 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.

  PMID: 19782872 RESULT

• Kim HC, Ko JH, Yoo DS, Lee SK. Spontaneous Resolution of Chronic Subdural Hematoma : Close Observation as a Treatment Strategy. J Korean Neurosurg Soc. 2016 Nov;59(6):628-636. doi: 10.3340/jkns.2016.59.6.628. Epub 2016 Oct 24.

  PMID: 27847578 RESULT

• Rojas-Villabona A, Mohamed S, Kennion O, Padmanabhan R, Siddiqui A, Prasad M, Mukerji N. A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation. Brain Spine. 2023 Sep 6;3:102672. doi: 10.1016/j.bas.2023.102672. eCollection 2023.

  PMID: 38021007 RESULT

• Akamatsu Y, Kashimura H, Kojima D, Yoshida J, Chika K, Komoribayashi N, Fujiwara S, Ogasawara K. Correlation Between Low-Density Hematoma at 1-Week Post-Middle Meningeal Artery Embolization and Rapid Resolution of Chronic Subdural Hematoma. World Neurosurg. 2024 Jan;181:e1088-e1092. doi: 10.1016/j.wneu.2023.11.045. Epub 2023 Nov 17.

  PMID: 37979682 RESULT

• Omura Y, Ishiguro T. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review. Front Neurol. 2023 Oct 10;14:1259647. doi: 10.3389/fneur.2023.1259647. eCollection 2023.

  PMID: 37881312 RESULT

• Salsano G, Fiaschi P, Laura G, Sonia M, Fontana V, Boni L, Zona G, Castellan L. Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1). Trials. 2025 Nov 18;26(1):517. doi: 10.1186/s13063-025-09131-y.

  PMID: 41254694 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Lucio Castellan, MD

  Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucio Castellan, MD

CONTACT

+390105552262; lucio.castellan@hsanmartino.it

Giancarlo Salsano, MD

CONTACT

+390105552262; giancarlo.salsano@hsanmartino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share