Status:
COMPLETED
Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Chronic Subdural Hematoma
At Risk of Post-operative Recurrence
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 clo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT04372147
Start Date
June 22 2020
End Date
October 23 2023
Last Update
September 23 2024
Active Locations (12)
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1
Hôpital d'instruction des armées de Percy
Clamart, France, 92190
2
Hôpital Beaujon
Clichy, France, 92110
3
Hôpital Henri-Mondor
Créteil, France, 94010
4
CHU Lille (Hôpital Roger Salengro)
Lille, France, 59037