Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)
- Conditions
- Chronic Subdural HematomaAt Risk of Post-operative RecurrenceBurr-hole Surgery
- Interventions
- Procedure: MMA embolization
- Registration Number
- NCT04372147
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 342
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group MMA embolization MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care
- Primary Outcome Measures
Name Time Method SDH recurrence 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
- Secondary Outcome Measures
Name Time Method disability and dependency 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)hospital stay 6 months - Total cumulative duration of hospital stay, during the 6 months follow-up period, directly or indirectly related to the SDH
complication rates 6 months - Minor and major embolization procedure-related complication rates
repeated surgery 6 months - Rate of repeated surgery for a homolateral SDH recurrence during the 6 months follow-up period
mortality 1 and 6 months - Mortality rate at 1 and 6 months
Trial Locations
- Locations (12)
Fondation Rothschild
🇫🇷Paris, France
CHU Tours
🇫🇷Tours, France
Hôpital d'instruction des armées de Percy
🇫🇷Clamart, France
Hôpital Beaujon
🇫🇷Clichy, France
Hôpital Henri-Mondor
🇫🇷Créteil, France
CHU Lille (Hôpital Roger Salengro)
🇫🇷Lille, France
CHU de Limoges
🇫🇷Limoges, France
Hôpital Nord (CHU MARSEILLE)
🇫🇷Marseille, France
CHU de Marseille
🇫🇷Marseille, France
Hôpital Lariboisière
🇫🇷Paris, France
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Sainte Anne
🇫🇷Paris, France