Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas
ConditionChronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLahey Clinic
About this trial
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
Eligibility criteria
Qualifiers
Subject is 18 years of age or older.
Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
Pre-randomization modified Rankin Score (mRS) ≤3
Subdural Hematoma Size
Disqualifiers
Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.
Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH <5mm and not requiring treatment is permitted.
Subject presents with Glasgow Coma Scale < 9
Markwalder assessment >4
Trial design
Treatments tested in this trial
- embolization therapy Bilateral
- embolization therapy Unilateral
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov