The MEMBRANE trial published in JAMA Neurology showed that middle meningeal artery embolization with TRUFILL n-BCA reduced chronic subdural hematoma recurrence and repeat interventions by 47% compared with standard care alone.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
New results from the randomized Phase 3 MEMBRANE trial, published in JAMA Neurology, showed that middle meningeal artery embolization (MMAE) using TRUFILL n-BCA significantly reduced chronic subdural hematoma (cSDH) recurrence and re-intervention compared with standard of care (SOC) alone.
The prospective, multicenter, open-label study enrolled 376 patients across 30 sites in the United States and China. Researchers evaluated the role of MMA embolization in both surgical and non-surgical treatment pathways for chronic subdural hematoma, a condition that frequently affects older adults and carries a substantial risk of recurrence.
Patients who received MMA embolization plus standard care were significantly less likely to experience residual or recurrent hematoma greater than 10 mm or require surgical re-intervention within six months. The treatment approach reduced the odds of reaching this composite primary endpoint by 47% compared with standard care alone.
Growing Role of MMA Embolization in cSDH Management
Chronic subdural hematoma occurs when blood gradually accumulates between the brain surface and the dura mater, often following minor head trauma. The condition is increasingly common in aging populations, particularly among patients taking anticoagulants or antiplatelet medications.
Traditional management relies on observation or surgical drainage, but recurrence rates remain clinically significant. MMA embolization targets the middle meningeal artery, a key contributor to the inflammatory and vascular processes that drive hematoma persistence and recurrence. By blocking abnormal blood supply to the hematoma membrane, embolization may promote more durable resolution.
TRUFILL n-BCA is a liquid embolic agent used during the procedure to permanently occlude targeted blood vessels.
Key Clinical Findings from the MEMBRANE Study
The trial met its primary endpoint, demonstrating a meaningful reduction in disease recurrence or progression when MMA embolization was added to standard care.
Additional findings further supported the intervention’s clinical value:
- A 47% reduction in the odds of hematoma recurrence, progression, or repeat surgery within six months.
- Numerically lower all-cause mortality at six months in the embolization group compared with standard care alone (3.3% vs. 8.4%).
- Good functional outcomes at three months in 85.3% of patients receiving MMA embolization versus 77.0% in the standard care group, meeting the study’s non-inferiority threshold.
- Procedural success in 98.9% of embolization cases, highlighting the feasibility of the technique across participating centers.
The findings suggest that MMA embolization can improve long-term disease control without compromising functional recovery.
Clinical Implications
According to Johnson & Johnson MedTech, the MEMBRANE trial adds important randomized evidence supporting embolization as an adjunct treatment for chronic subdural hematoma.
Christian Cuzick, Worldwide President of Neurovascular at Johnson & Johnson MedTech, said the study reinforces the growing body of evidence supporting MMA embolization as a valuable treatment strategy that can reduce recurrence and the need for additional procedures.
Study co-principal investigator Dr. Chris Kellner of the Mount Sinai Health System noted that chronic subdural hematoma remains particularly challenging in elderly and medically complex patients, making durable treatment approaches especially important.
Clinical Path Forward
Publication of the MEMBRANE results in JAMA Neurology further strengthens the clinical case for incorporating middle meningeal artery embolization into comprehensive chronic subdural hematoma care. As evidence from randomized studies continues to accumulate, MMA embolization is emerging as a potential new standard adjunctive therapy across both surgical and non-surgical treatment settings.
What This Means for Patients
Chronic subdural hematoma is a condition in which blood slowly collects around the brain, often after a minor head injury. It is more common in older adults and can cause symptoms such as headaches, confusion, memory problems, weakness, difficulty walking, or frequent falls. Even after treatment, the condition can sometimes return and require additional procedures.
The MEMBRANE study suggests that adding middle meningeal artery embolization (MMAE) to standard treatment may help lower the chance of the hematoma coming back. During this minimally invasive procedure, doctors use a thin tube inserted through a blood vessel to block tiny blood vessels that may contribute to ongoing bleeding around the brain. Patients who received MMAE were less likely to experience recurrence or need another procedure within six months compared with those who received standard treatment alone. These findings may offer patients and physicians a new option to improve long-term outcomes and reduce the need for repeat interventions.
Reference
Johnson & Johnson Highlights Positive Results from MEMBRANE Trial Published in JAMA Neurology
About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.