- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372147
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eimad Shotar, MD
- Phone Number: +33 1 84 82 73 66
- Email: eimad.shotar@aphp.fr
Study Contact Backup
- Name: Anne Bissery
- Phone Number: +33 1 42 16 24 32
- Email: anne.bissery@aphp.fr
Study Locations
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Clamart, France, 92190
- Not yet recruiting
- Hôpital d'instruction des armées de Percy
-
Contact:
- Mathilde FOUET, MD
- Phone Number: +33 670547341
- Email: mathilde.fouet@intradef.gouv.fr
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Clichy, France, 92110
- Not yet recruiting
- Hopital Beaujon
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Contact:
- Stéphane GOUTAGNY, MD
- Phone Number: +33 140845229
- Email: stephane.goutagny@aphp.fr
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Créteil, France, 94010
- Not yet recruiting
- Hopital Henri-Mondor
-
Contact:
- Titien TUILIER, MD
- Phone Number: +33 689930589
- Email: titien.tuilier@gmail.com
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Lille, France, 59037
- Not yet recruiting
- CHU Lille (Hôpital Roger Salengro)
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Contact:
- Nicolas BRICOUT, MD
- Phone Number: +33 320446468
- Email: nicolas1.bricout@chru-lille.fr
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Limoges, France, 87042
- Not yet recruiting
- CHU de Limoges
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Contact:
- Charbel MOUNAYER, MD, PhD
- Phone Number: +33 555058011
- Email: charbel.mounayer@unilim.fr
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Marseille, France, 13015
- Not yet recruiting
- Hôpital Nord (CHU MARSEILLE)
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Contact:
- Lucas TROUDE, MD
- Phone Number: +33 491968620
- Email: Lucas.troude@ap-hm.fr
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Marseille, France, 13385
- Not yet recruiting
- CHU de Marseille
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Contact:
- Hervé BRUNEL, MD
- Phone Number: +33 413429051
- Email: herve.brunel@ap-hm.fr
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Paris, France, 75010
- Not yet recruiting
- Hopital Lariboisiere
-
Contact:
- Emmanuel HOUDART, MD, PhD
- Phone Number: +33 1 49 95 61 35
- Email: emmanuel.houdart@aphp.fr
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Paris, France, 75013
- Recruiting
- Hôpital Pitié-Salpétrière
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Contact:
- Eimad Shotar, MD
- Phone Number: +33 184827366
- Email: eimad.shotar@aphp.fr
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Paris, France, 75014
- Not yet recruiting
- Hopital Sainte Anne
-
Contact:
- Olivier NAGARRA, MD, PhD
- Phone Number: +33 145658574
- Email: o.naggara@ch-sainte-anne.fr
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Paris, France, 75019
- Not yet recruiting
- Fondation Rothschild
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Contact:
- Simon ESCALARD, MD
- Phone Number: +33 695196516
- Email: sescalard@for.paris
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Tours, France, 37044
- Not yet recruiting
- CHU Tours
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Contact:
- Denis HERBRETEAU, MD, PhD
- Phone Number: +33 234379615
- Email: denis.herbreteau@univ-tours.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Investigators
- Principal Investigator: Eimad Shotar, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Disease Attributes
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Recurrence
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
Other Study ID Numbers
- APHP180574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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