The AGAINST Protocol: Augmentative Craniotomy in Stroke (AGAINST)
Middle Cerebral Artery Occlusion With Cerebral Infarction
About this trial
This is an interventional treatment trial for Middle Cerebral Artery Occlusion With Cerebral Infarction
Eligibility Criteria
Inclusion Criteria: Only MCA ischemic strokes have been considered, with no distinctions between the execution of precedent treatment (thrombolysis and/or thrombectomy) Patients' age <75 years old. NIHSS >1a, >14 for right sided lesions, >15 for left sided lesions Symptoms onset <48 hours before surgery or conservative treatment Neuroradiological findings: unilateral ischemic infarction of at least 1/3 of MCA territory is involved. Ischemic core volume>140ml. Hypodensity on head CT within the first 6 hours of stroke onset involving one-third or more of the MCA territory, early midline shift, and magnetic resonance imaging diffusion-weighted imaging volume within 6 hours ≥80 mL. informed consent by the patient him/herself, his/her legal representative, adjudication by a legally competent judge, or by an independent physician Exclusion Criteria: - presence of concomitant or associated brain lesion presence of concomitant comorbidities or other clear contraindications for treatment participation in any other interventional trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Decompressive hemicraniectomy
Augmentative craniotomy
The procedure of hemicraniectomy is performed in the same way as the augmentative craniotomy from skin incision to dural augmentation. Then, the myo-cutaneous flaps are reapproximated and sealed and the operculum is secured. Then, cranioplasty with autologous bone will be performed within 6-months after the hemicraniectomy.
Surgical incision according to Kempe is performed to obtain a better vascularization of the myo-cutaneous flap, to guarantee a larger surgical exposition and to facilitate the closure. The incision starts from "widow's peak" and arrives 1 cm upon the inion and it is performed parallel to the midline, 3 cm from it. Then a second incision is performed from the center of the first one and it will be extended inferiorly to the tragus. Burr holes will be performed in the frontal-basal region (keyhole), temporal region and superior and medial to the inion. Supplementary burr holes can be performed. Then, a large frontal-temporal-parietal-occipital craniotomy not smaller than 12x15 cm is performed. Then dural augmentation is performed with the positioning of a dural patch. The operculum is repositioned through the application of 5 titanium clamps secured with screws 1 cm above the margin of the craniotomy. The myo-cutaneous flaps are reapproximated and sealed.