Johnson & Johnson: MEMBRANE shows MMA embolization with TRUFILL n‑BCA reduces cSDH recurrence
- Randomized MEMBRANE trial enrolled 376 patients across 30 U.S. and Chinese sites.
- SOC plus MMA embolization with TRUFILL n‑BCA reduced the odds of the composite primary endpoint (residual or re‑accumulation of cSDH >10mm or need for surgical re‑intervention within 6 months) by 47% versus SOC alone.
- All‑cause mortality at six months was numerically lower with embolization (3.3% vs 8.4%).
- Procedural success was 98.9%, and at 3 months 85.3% vs 77.0% achieved good functional outcomes with MMAe meeting the trial’s non‑inferiority threshold.
Study design
MEMBRANE is a prospective, multicenter, open‑label randomized controlled trial that randomized 376 patients across 30 sites in the United States and China to evaluate middle meningeal artery embolization (MMAe) with TRUFILL n‑BCA added to standard of care (SOC) versus SOC alone for chronic subdural hematoma (cSDH) across surgical and non‑surgical treatment pathways.
Primary results
Participants treated with SOC plus MMAe with TRUFILL n‑BCA were significantly less likely to meet the prespecified composite primary end point—residual or re‑accumulation of cSDH >10mm or the need for surgical re‑intervention within 6 months—compared with SOC alone, corresponding to a 47% reduction in odds.
Additional findings
The embolization group had a numerically lower all‑cause mortality at six months (3.3% vs 8.4%). At 3 months, 85.3% versus 77.0% of patients achieved good functional outcomes and MMAe met the trial’s non‑inferiority threshold. Procedural success was high, with successful embolization in 98.9% of cases.
Conclusion
Publication of the MEMBRANE primary results in JAMA Neurology adds randomized clinical evidence supporting middle meningeal artery embolization with TRUFILL n‑BCA as part of comprehensive cSDH management to reduce recurrence and re‑intervention.
Source: J&J