Chronic Subdural Hematoma
Conditions
Keywords
Middle meningeal artery embolization
Brief summary
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.
Detailed description
The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (\< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 \[no disability\] to 6 \[death\]) at 6 months and complications related to endovascular procedure.
Interventions
PROCEDUREPost surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary outcome will be assesed by a blinded external core lab
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect. * Recent diagnosis or recurrence * Surgical treatment performed \< 72 hours * Informed consent signed by the patient or they responsible family member
Exclusion criteria
* Advanced disease with life expectancy \< 6 months * Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence \< 30 ml/min, allergy to iodinated contrast. * Unavailability for follow up st 6 months * Patient expressly refuses treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of chronic subdural hematoma | 6 months | Defined ad reappearance of symptomatic blood collection or whose thickness is \> 1 cm or which determines a deviation from the midline\> 5 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | 6 months | Measured by modified Rankin scale (range, 0 \[no disability\] to 6 \[death\]) |
| Safety of endovascular treatment | 6 months | Measured by complications related to endovascular procedure |
| Hematoma reabsorption speed | 6 months | Measured by hematoma volume after treatment on CT imaging |
| Cumulative days of hospital stay | 6 months | Measured in both groups (surgical alone and surgical plus endovascular) |
Countries
Spain
Contacts
Primary ContactAlejandro Tomasello, MD
Backup ContactJose Luis Cuevas, MD
Outcome results
None listed