Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

NCT ID: NCT06163547

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2027-01-01

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).

Detailed Description

Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.

The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.

First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).

Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.

Conditions

Chronic Subdural Hematomas; Cerebral Compression Due to Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - Surgery - No embolization (control)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2 - Surgery - MMA embolisation

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.

Group Type: EXPERIMENTAL

MMA embolization

Intervention Type: RADIATION

Middle meningeal artery embolization

Arm 3 - No surgery - Embolization accepted

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.

Group Type: ACTIVE_COMPARATOR

MMA embolization

Intervention Type: RADIATION

Middle meningeal artery embolization

Arm 4 - No surgery - Embolization not accepted

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MMA embolization

Middle meningeal artery embolization

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Aria Nouri

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aria Nouri

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Geneva University Hospitals

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Aria Nouri

Role: CONTACT

aria.nouri@hug.ch

+41795530958

Facility Contacts

Aria Nouri

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40335147 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-00848

Identifier Type: -

Identifier Source: org_study_id