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

NCT04372147 | Completed DMC

• 1 other identifier: APHP180574
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Chronic Subdural Hematoma; At Risk of Post-operative Recurrence; Burr-hole Surgery

Keywords

Chronic Subdural Hematoma; Burr-Hole Surgery; Recurrence; Middle Meningeal Artery; Embolization

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (5)

• repeated surgery

  6 months

• disability and dependency

  1 and 6 months

• mortality

  1 and 6 months

• hospital stay

  6 months

• complication rates

  6 months

Study Arms (2)

intervention group

EXPERIMENTAL

MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care

Procedure: MMA embolization

control group

NO INTERVENTION

standard medical care

Interventions

MMA embolization PROCEDURE

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• SDH evacuation by craniotomy or twist-drill craniostomy rather than burr-hole surgery
• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (12)

Hôpital d'instruction des armées de Percy

Clamart, 92190, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Henri-Mondor

Créteil, 94010, France

Location

CHU Lille (Hôpital Roger Salengro)

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Hôpital Nord (CHU MARSEILLE)

Marseille, 13015, France

Location

CHU de Marseille

Marseille, 13385, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Sainte Anne

Paris, 75014, France

Location

Fondation Rothschild

Paris, 75019, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (2)

• 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.

  PMID: 40471557 DERIVED

• 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.

  PMID: 38307722 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Eimad Shotar, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter open label randomized controlled trial. Eligible patients will be assigned either to the intervention or a control arm

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: June 22, 2020
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (12)