Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

NCT06163547 | Recruiting DMC

• 1 other identifier: 2023-00848
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

Conditions

Chronic Subdural Hematomas; Cerebral Compression Due to Injury

Outcome Measures

Primary Outcomes (3)

• Recurrence of cSDH - 1

  Surgical reoperation

  6-months

• Recurrence of cSDH - 2

  Neurological deterioration due to a cSDH after evacuation

  6-months

• Recurrence of cSDH - 3

  Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up

  6-months

Secondary Outcomes (8)

• Additional clinical outcomes - 1

  6-months

• Additional clinical outcomes - 2

  6-months

• Additional clinical outcomes - 3

  6-months

• Additional clinical outcomes - 4

  6-months

• Additional clinical outcomes - 5

  6-months

Study Arms (4)

Arm 1 - Surgery - No embolization (control)

NO INTERVENTION

Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management.

Arm 2 - Surgery - MMA embolisation

EXPERIMENTAL

Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management.

Radiation: MMA embolization

Arm 3 - No surgery - Embolization accepted

ACTIVE COMPARATOR

Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3.

Radiation: MMA embolization

Arm 4 - No surgery - Embolization not accepted

NO INTERVENTION

Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4.

Interventions

MMA embolization RADIATION

Middle meningeal artery embolization

Arm 2 - Surgery - MMA embolisation; Arm 3 - No surgery - Embolization accepted

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-100
• Consent possible
• cSDH located at the convexities
• Patients with symptomatic cSDH
• Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment

You may not qualify if:

• Consent not possible
• Pregnancy
• Prisoner
• Angiography contraindication
• Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
• Previous surgery for cSDH

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

Geneva University Hospitals

Geneva, Switzerland

RECRUITING

EOC

Lugano, Switzerland

RECRUITING

Related Publications (1)

• Al Awadhi A, Mollica C, Da Broi M, Molliqaj G, Hofmeister J, Rosi A, Bernava G, Machi P, Morel S, Cardia A, Meling TR, Schaller K, Nouri A. Middle meningeal artery (MMA) embolisation for chronic subdural haematomas: rationale and design for the STOp Recurrence of MMA Bleeding (STORMM) randomised control trial-a study protocol. BMJ Open. 2025 May 6;15(5):e092014. doi: 10.1136/bmjopen-2024-092014.

  PMID: 40335147 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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

Study Officials

• Aria Nouri

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aria Nouri

CONTACT

+41795530958; aria.nouri@hug.ch

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: Dr.

Model Details: This study is a multicentre randomised-controlled trial.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 11, 2023
• Study Start: February 18, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)