ArticleTrials2025
Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1).
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06274580 (Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms: a Multicentre Randomized Trial
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Updated systematic review of current randomised controlled trials in chronic subdural haematoma.Acta neurochirurgica · 2025Pooled it
- Current Status of Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: An International Perspective Including Japan.Journal of neuroendovascular therapy · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic subdural hematoma (cSDH) is a common neurosurgical condition that is prevalent in elderly patients. There are no well-defined guidelines for cSDH and management strategies vary widely among physicians and institutions, and this variability is expressed in the literature. In general, conservative management is reserved to patients who are asymptomatic or have minor symptoms with mild mass effect. Spontaneous resolution of cSDH is an unusual phenomenon and middle meningeal artery (MMA) embolization seems to reduce the recurrence and progression rate of SDH compared to conventional treatments in multiple cohort studies. A randomized controlled trial is warranted to determine the effectiveness and safety of endovascular embolization for cSDH and whether MMA embolization is superior to conservative management in reducing the progression rate and surgical rescue event.
methodsThis is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE design) to assess the superiority of MMA embolization compared to conservative treatment. A total of 300 patients are planned to be randomized 1:1 to receive MMA embolization (intervention) or conventional treatments (control). The primary outcome is the treatment arm failure which is defined as a composite of incomplete hematoma resolution or surgical rescue within 6 months follow-up. Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief or symptoms that developed with continuous growth of the cSDH. In case of bilateral cSDH, the treatment failure occurred when primary outcomes criteria are satisfied for at least one of the two hematomas. DISCUSSION: This multi-centre randomized controlled trial is needed to evaluate the benefit-to-risk ratio of primary embolization of the MMA to facilitate resolution and prevent rescue surgical evacuation of cSDH. If MMA embolization turns out to be superior to conservative management in this trial, this may prompt further confirmatory trials and, at best, may change clinical practice and guideline recommendations.
trial registrationClinicalTrials.gov. Identifier: NCT06274580, Registered on 6 February 2024. This protocol was developed in accordance with the SPIRIT Checklist and by use of the structured study protocol template provided by BMC Trials.
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