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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Clamart, France, 92190
        • Not yet recruiting
        • Hôpital d'instruction des armées de Percy
        • Contact:
      • Clichy, France, 92110
        • Not yet recruiting
        • Hopital Beaujon
        • Contact:
      • Créteil, France, 94010
        • Not yet recruiting
        • Hopital Henri-Mondor
        • Contact:
      • Lille, France, 59037
        • Not yet recruiting
        • CHU Lille (Hôpital Roger Salengro)
        • Contact:
      • Limoges, France, 87042
        • Not yet recruiting
        • CHU de Limoges
        • Contact:
      • Marseille, France, 13015
        • Not yet recruiting
        • Hôpital Nord (CHU MARSEILLE)
        • Contact:
      • Marseille, France, 13385
        • Not yet recruiting
        • CHU de Marseille
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • Hopital Lariboisiere
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Hôpital Pitié-Salpétrière
        • Contact:
      • Paris, France, 75014
        • Not yet recruiting
        • Hopital Sainte Anne
        • Contact:
      • Paris, France, 75019
        • Not yet recruiting
        • Fondation Rothschild
        • Contact:
      • Tours, France, 37044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care
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
No Intervention: control group
standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDH recurrence
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
repeated surgery
Time Frame: 6 months
- Rate of repeated surgery for a homolateral SDH recurrence during the 6 months follow-up period
6 months
disability and dependency
Time Frame: 1 and 6 months

- 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)

1 and 6 months
mortality
Time Frame: 1 and 6 months
- Mortality rate at 1 and 6 months
1 and 6 months
hospital stay
Time Frame: 6 months
- Total cumulative duration of hospital stay, during the 6 months follow-up period, directly or indirectly related to the SDH
6 months
complication rates
Time Frame: 6 months
- Minor and major embolization procedure-related complication rates
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eimad Shotar, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 26, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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