Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

Status:

ongoing

Aims:

Chronic subdural hematomas (cSDH) are liquefied hemorrhages between the inner and outer sheath of the brain caused by injuries of bridging veins following minor to major head trauma. cSDH are the most common intracranial hemorrhages with a yearly incidence of 1-5,3/100.000 inhabitants. Burr-hole trepanation with evacuation of the cSDH is the standard therapy. Up to 40% of patients suffer from recurrent cSDH which increases morbidity and mortality due to re-operations. Endovascular treatment with embolization of the middle meningeal artery (MMA) has been identified as a new therapeutic approach. The aim of this trial is to significantly reduce the number of patients with recurrent cSDH needing treatment after burr-hole trepanation and additional embolization of the MMA.

Activities/Methods:

This monocentric, prospective randomized controlled trial (RCT) with two arms will include 138 patients. All subjects will be treated according to Good Clinical Practise. Indication and performance of burr-hole trepanation and evacuation of the cSDHs will be conducted independent of this study. After written consent to the participation in the trial the subjects will be randomized. In the intervention group additional embolization of the branches of the MMA will be performed. Subjects in the control arm will only receive the standard therapy. The following questions will be investigated.

Null hypothesis: Additional embolization of the MMA will not reduce the recurrence rate of cSDH after burr-hole trepanation and evacuation within 3 months.

Secondary hypothesis 1: Additional embolization of the MMA can reduce the occurrence of neurological symptoms.

Secondary hypothesis 2: Additional embolization of the MMA can reduce associated complications.

Secondary hypothesis 3: In patients with cSDH emerging or pre-existing factor XIII deficiency (<70%) increases the risk for recurrent cSDH.

Secondary hypothesis 4: The genetic variants F13A1 rs2815822 and F13B rs12134960 predispose for factor XIII deficiency (<70%) in patients with cSDH.

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