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Glue embolization may cut repeat brain bleed surgery

NCT ID NCT04816591

Disease control Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tested whether adding a glue-like embolization to standard care reduces the chance of a chronic subdural hematoma coming back or needing another surgery. 376 adults with this type of brain bleed were randomly assigned to standard care alone or standard care plus the embolization procedure. The main goal was to see if the embolization group had fewer hematoma recurrences or repeat operations at 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
What this could lead to
If successful, this procedure could reduce the need for repeat surgeries and improve recovery in people with chronic subdural hematomas.
What could go wrong
This is a completed study, but results are not yet widely confirmed. The procedure carries risks like any embolization, and benefits may vary by patient.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

376 people

The number who actually took part.

Started

May 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pre-randomization mRS \</= 3 * Confirmed diagnosis of chronic subdural hematoma * Completed informed consent Exclusion Criteria: * Acute subdural hematoma * Prior treatment of target subdural hematoma * Markwalder assessment \>/= 3 * Glasgow Coma Scale \< 9 * Presumed microbial superinfection * CT or MRI evidence of intracranial tumor or mass lesion * Life expectancy \< 1 year * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study * Current involvement in another clinical trial that may confound study endpoints

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic subdural hematoma

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital of Research

    Pittsburgh, Pennsylvania, 15212, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Carondelet St Joseph's Hospital

    Tucson, Arizona, 85710, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Hartford Hospital

    Hartford, Connecticut, 06032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • John Muir Physician Network Clinical Research Center

    Walnut Creek, California, 94598, United States

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 02115, United States

  • Memorial Health University Health Center

    Savannah, Georgia, 31405, United States

  • Mercy Health St Vincent Medical Center

    Toledo, Ohio, 43608, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008, China

  • Ohio Health

    Columbus, Ohio, 43214, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127, China

  • Semmes Murphey Foundation

    Memphis, Tennessee, 38120, United States

  • Swedish Medical Center

    Englewood, Colorado, 80113, United States

  • Texas Stroke Institute

    Plano, Texas, 75075, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Miami - Jackson Memorial Hospital

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wellstar Health System

    Marietta, Georgia, 30067, United States

  • West Virginia Hospital

    Morgantown, West Virginia, 26506, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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