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Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Study acronym: CHESS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 65 words
    • Site details revised at 1 of 31 sites
    v13
  2. Study sites: 30 to 31v12
  3. Study sites: 32 to 30v11
  4. Study sites: 33 to 32
    • Eligibility criteria shortened, about 21 words
    v10
  5. Primary and study completion dates: Sep 2028 to Feb 2029
    • Eligibility criteria expanded, about 133 words
    • Site details revised at 3 of 33 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 7 of 33 sitesv8
  2. Study sites: 30 to 33v7
  3. Site details revised at 2 of 30 sitesv6
  4. Site details revised at 5 of 30 sitesv5
  5. Study sites: 1 to 30v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Nov 1, 2024
    • Site details revised
    v3
  7. Primary and study completion dates: Sep 2029 to Sep 2028v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.
Trial Details
NCT Number NCT06347796
Lead Sponsor The University of Texas Medical Branch, Galveston
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Chronic Subdural Hematoma
Related terms Hematoma, Subdural, Chronic
Enrollment 520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov