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

Last updated: September 19, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

MMA embolization

Clinical Study ID

NCT04372147
APHP180574
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient:

  • Aged ≥ 18 years

  • Operated for a SDH recurrence or operated for a first episode of SDH if at least oneof 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 asupport person has signed an informed consent

Exclusion

Exclusion Criteria:

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

  • Beyond 7 days after the index surgery (surgery for recurrent SDH or first surgery incase 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

  • History of allergy to a iodinated contrast agent

  • Procedure deemed unachievable under local anesthesia (because of patient agitationor discomfort for instance) in a patient with a contraindication to both conscioussedation and general anesthesia.

  • Patient refusal

  • Patient for whom follow-up is deemed problematic (living abroad or homeless forinstance )

  • Patients under legal guardianship or trusteeship

Study Design

Total Participants: 342
Treatment Group(s): 1
Primary Treatment: MMA embolization
Phase:
Study Start date:
June 22, 2020
Estimated Completion Date:
October 23, 2023

Study 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.

Connect with a study center

  • Hôpital d'instruction des armées de Percy

    Clamart, 92190
    France

    Site Not Available

  • Hôpital Beaujon

    Clichy, 92110
    France

    Site Not Available

  • Hôpital Henri-Mondor

    Créteil, 94010
    France

    Site Not Available

  • CHU Lille (Hôpital Roger Salengro)

    Lille, 59037
    France

    Site Not Available

  • CHU de Limoges

    Limoges, 87042
    France

    Site Not Available

  • CHU de Marseille

    Marseille, 13385
    France

    Site Not Available

  • Hôpital Nord (CHU MARSEILLE)

    Marseille, 13015
    France

    Site Not Available

  • Fondation Rothschild

    Paris, 75019
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, 75010
    France

    Site Not Available

  • Hôpital Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Hôpital Sainte Anne

    Paris, 75014
    France

    Site Not Available

  • CHU Tours

    Tours, 37044
    France

    Site Not Available

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