Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Chronic Subdural Hematomas Clinical Trial

— STORMM  

Official title:

Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163547
• Other study ID #: 2023-00848
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: Aria Nouri
• Phone: +41795530958
• Email: aria.nouri[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• MMA embolization
Middle meningeal artery embolization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of cSDH - 1	Surgical reoperation	6-months
Primary	Recurrence of cSDH - 2	Neurological deterioration due to a cSDH after evacuation	6-months
Primary	Recurrence of cSDH - 3	Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up	6-months
Secondary	Additional clinical outcomes - 1	Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)	6-months
Secondary	Additional clinical outcomes - 2	modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)	6-months
Secondary	Additional clinical outcomes - 3	Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)	6-months
Secondary	Additional clinical outcomes - 4	Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)	6-months
Secondary	Additional clinical outcomes - 5	Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome)	6-months
Secondary	Additional clinical outcomes - 6	Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome)	6-months
Secondary	Additional clinical outcomes - 7	Mortality rate	6-months
Secondary	Additional clinical outcomes - 8	Re-hospitalisation for all causes	6-months