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Chronic Subdural HematomaEMPROTECTNCT04372147

Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)

A study testing MMA embolization in people with Chronic Subdural Hematoma and At Risk of Post-operative Recurrence, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MMA embolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
12 sitesFrance
Study dates
22 Jun 2020to 23 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient:
  • Aged ≥ 18 years
  • Operated for a SDH recurrence or operated for a first episode of SDH if at least one of the following recurrence risk factors is present:
  • Chronic alcoholism defined by a daily alcohol consumption > 30g/day
  • Or liver cirrhosis
  • Or antiplatelet therapy
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  • Or anticoagulant therapy
  • Or thrombocytopenia with a platelet count < 100 x10(3) per µL
  • Or surgery without use of external drain
  • With affiliation to a social security scheme
  • Having signed an informed consent form or for whom a delegate close relative or a support person has signed an informed consent

Who cannot join

  • SDH evacuation by craniotomy or twist-drill craniostomy rather than burr-hole surgery
  • Beyond 7 days after the index surgery (surgery for recurrent SDH or first surgery in case of a risk factor as indicated in the inclusion criteria)
  • Functionally dependant patient with an mRS score ≥ 4 before the SDH
  • Patient with a life expectancy < 6 months
  • Patient with renal failure as defined by a creatinine clearance < 30 ml/min
  • Pregnancy
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  • History of allergy to a iodinated contrast agent
  • Procedure deemed unachievable under local anesthesia (because of patient agitation or discomfort for instance) in a patient with a contraindication to both conscious sedation and general anesthesia.
  • Patient refusal
  • Patient for whom follow-up is deemed problematic (living abroad or homeless for instance )
  • Patients under legal guardianship or trusteeship

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Hôpital d'instruction des armées de Percy

    Clamart, 92190

  • Hôpital Beaujon

    Clichy, 92110

  • Hôpital Henri-Mondor

    Créteil, 94010

  • CHU Lille (Hôpital Roger Salengro)

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Hôpital Nord (CHU MARSEILLE)

    Marseille, 13015

  • CHU de Marseille

    Marseille, 13385

  • Hôpital Lariboisière

    Paris, 75010

  • Hôpital Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Sainte Anne

    Paris, 75014

  • Fondation Rothschild

    Paris, 75019

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

Official title: Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial

Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

Read the detailed description

Introduction: chronic SDHs are some of the most frequently encountered neurosurgical emergencies. The gold standard treatment of symptomatic chronic SDHs is burr-hole surgery followed by temporary closed system drainage. Post-operative recurrence rates may be as high as 10 to 20% and are a major source of morbidity and repeated surgery. MMA embolization is a promising minimally invasive procedure recently proposed as a treatment of chronic SDH. It is hypothesized that post-operative MMA embolization may reduce recurrence rate in patients at high risk of recurrence.

Aims: the primary objective of the trial is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical treatment in patients at high risk of post-operative recurrence. Secondary objectives include evaluating the impact of post-operative MMA embolization on rate of recurrence requiring new surgery (at 6 months), rate of functional dependency (at 1 and 6 months) , mortality (at 1 and 6 months) , cumulative hospital stay duration, related to the SDH, and complication rate at 6 months.

Methods: multicenter open label randomized controlled trial. Eligible patients will be assigned either to the intervention or a control arm through blocked randomization with randomblock sizes and stratified on the center, antiplatelet/anticoagulant therapy and unilateral vs bilateral SDH. Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care. Patients in the control group will receive standard medical care only. Outcomes will be evaluated at 1 and 6 months. The primary outcome measure will be the rate of chronic SDH recurrence 6 months after index burr-hole surgery, as defined bellow. In order to demonstrate a decrease in recurrence rate from 15 to 5% between the intervention and control arms with a power of 80%, bilateral global alpha risk of 5%, with two planned sequential tests according to the method of Lan \& Demets, and 20% patients lost to follow-up, 342 patients are required, 171 in each arm. The primary outcome will be analyzed according to intention to treat.

Being tested
MMA embolization
Keywords
Chronic Subdural Hematoma, Burr-Hole Surgery, Recurrence, Middle Meningeal Artery, Embolization
Medical subject headings
Hematoma, Subdural, Chronic, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MMA embolizationProcedure or surgery

    Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care

Study groups in NCT04372147
Study groupRoleWhat they receive
intervention groupExperimentalMMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care
Receives: Procedure: MMA embolization
control groupNo interventionstandard medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SDH recurrence

    Rate of chronic subdural hematoma (SDH) recurrence 6 months after index burr-hole surgery, defined as:

    • Reappearance of a homolateral SDH with a midline shift > 5mm or a symptomatic homolateral SDH, including leading to death
    • Or, the presence of a homolateral SDH > 10mm in maximal thickness on the 6 months control head CT scan
    • Or, the need for repeated surgery for a homolateral SDH recurrence
    • Or, the need for a new hospital admission in relation to a homolateral SDH recurrence

    Measured: 6 months

Secondary outcomes (5)

  1. repeated surgery

    • Rate of repeated surgery for a homolateral SDH recurrence during the 6 months follow-up period

    Measured: 6 months

  2. disability and dependency

    • Rate of disability and dependency at 1 and 6 months, defined by a modified Rankin Scale (mRS) score ≥ 4.

    The mRS is an ordered scale coded from 0 (no symptoms at all) through 5 (severe disability) 6 (death)

    Measured: 1 and 6 months

  3. mortality

    • Mortality rate at 1 and 6 months

    Measured: 1 and 6 months

  4. hospital stay

    • Total cumulative duration of hospital stay, during the 6 months follow-up period, directly or indirectly related to the SDH

    Measured: 6 months

  5. complication rates

    • Minor and major embolization procedure-related complication rates

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start22 Jun 2020
  3. Primary completion23 Oct 2023
  4. Study completion23 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter open label randomized controlled trial. Eligible patients will be assigned either to the intervention or a control arm
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04372147
Sponsor's protocol ID
APHP180574
Acronym
EMPROTECT
Status last verified
Jan 2024
First submitted
29 Apr 2020
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Publications

  • Shotar E, Mathon B, Salle H, Rouchaud A, Mounayer C, Bricout N, Lejeune JP, Janot K, Amelot A, Naggara O, Roux A, Goutagny S, Guedon A, Houdart E, Brunel H, Hak JF, Troude L, Dufour H, Bernat AL, Tuilier T, Bresson D, Apra C, Fouet M, Escalard S, Chauvet D, Premat K, Lebbah S, Dechartres A, Clarencon F; EMPROTECT Investigators. Meningeal Embolization for Preventing Chronic Subdural Hematoma Recurrence After Surgery: The EMPROTECT Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):127-135. doi: 10.1001/jama.2025.7583.

    PubMed 40471557

  • Shotar E, Mathon B, Rouchaud A, Mounayer C, Salle H, Bricout N, Lejeune JP, Janot K, Zemmoura I, Naggara O, Roux A, Goutagny S, Guedon A, Brunel H, Troude L, Dufour H, Bernat AL, Tuilier T, Bresson D, Apra C, Fouet M, Escalard S, Chauvet D, Baptiste A, Lebbah S, Dechartres A, Clarencon F; EMPROTECT collaboration. Embolization of the middle meningeal artery for the prevention of chronic subdural hematoma recurrence in high-risk patients: a randomized controlled trial-the EMPROTECT study protocol. J Neurointerv Surg. 2024 Dec 26;17(e1):e172-e177. doi: 10.1136/jnis-2023-021249.

    PubMed 38307722

Questions about this trial

What is this clinical trial studying?

A study testing MMA embolization in people with Chronic Subdural Hematoma and At Risk of Post-operative Recurrence, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SDH recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04372147, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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