Strokectomy in Malignant Cerebral Media Infarction
ConditionStroke, Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rostock
About this trial
Decompressive hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage, wherefore, strokectomy with resection of necrotic tissue has been proposed in some case series as an alternative surgical option. Thus, the aim of this study is to perform a pilot study by including patients with malignant MCA infarction and to check the feasibility of this specific surgical treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Ischemic middle cerebral artery (MCA) infarction at least two thirds of the MCA territory
Clinical symptoms of acute unilateral MCA infarction less than 48 hours prior to the initiation of treatment
Disqualifiers
Preexisting modified Rankin Scale >2
Absence of pupillary reflexes or GCS <6
Intracerebral hemorrhage or other associated brain lesions
Contraindications for surgery
Trial design
Design model
Single group
Treatments tested in this trial
Strokectomy/Necrosectomy
Procedure/SurgeryAfter obtaining CT-/MRT-perfusion, the infarcted area (e.g. infarct core) of malignant MCA-infarction is localized. By using the neuronavigation, surgical resection of necrotic tissue is performed in a non-eloquent area until the space occupying effect is released. At the end of the surgery, the bone flap is reinserted and fixated.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Necrosectomy/StrokectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of resurgery after necrosectomy of malignant MCA-infarction
After the surgical treatment, the patients will be treated in the neurointensive care unit. During the clinical course, the necessity to perform a secondary surgery (e.g. hemicraniectomy) will be observed. For the safety of the patients, intracranial pressure monitoring will be continously performed as well.
Time frame
up to 2 weeksSecondary outcomes
1
Surgical complications
The rate of wound infection, other infections, postoperative hemorrhage and postoperative seizure will be documented during the clinical course and follow-up.
Time frame
up to 3 months2
Functional outcome via modified Rankin Scale (mRS; range 0-6; 0-3: favorable outcome, 4-6: unfavorable outcome) at 3 months
After 3 months, the functional outcome will be evaluated by modified Rankin Scale.
Time frame
up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov