embolization of the middle meningeal artery for the prevention of chronic subdural hematoma recurrence in high risk patients (emprotect)

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

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.

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.

Eligibility criteria:
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

Keywords: chronic subdural hematoma burr-hole surgery recurrence middle meningeal artery embolization