Clinical trial NCT02002234: Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI)
Official title: Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI): A Single Center Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infarction
Keywords: Hemicraniectomy, stroke, decompressive surgery, HeMMI
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A single-centered, randomized, controlled clinical trial comparing standardized medical care alone with standardized medical care and decompressive hemicraniectomy to determine the effectiveness of decompressive surgery more definitively in patients with clinical signs of infarction of the Middle Carotid Artery (MCA) territory.

Detailed description: A single-centered, randomized, controlled clinical trial comparing standardized medical care alone with standardized medical care and decompressive hemicraniectomy to determine the effectiveness of decompressive surgery more definitively in patients with clinical signs of infarction of the MCA territory and and who arrived at the hospital within 72 hours of symptom onset.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 to 65 years old who presented with clinical signs of infarction of the MCA territory and who arrived at the hospital within 72 hours of symptom onset. Other inclusion criteria included a Glasgow coma score (GCS) of 6 to14 in patients with right MCA infarction or GCS 5 to 9 in patients with left MCA infarction (adjusted to account for effect on speech deficit on GCS scores), or GCS of 15 on arrival but subsequently deteriorated neurologically as defined by a score of ≥1 on the level of consciousness item of the National Institutes of Health Stroke Scale (NIHSS);computed tomography (CT) scan of the head showing ischemic changes corresponding to more than 50% of the MCA territory with or without involvement of other vascular territories;and written informed consent from the patient or a legal representative.

Exclusion Criteria:

* Patients with previous disabling neurological disease, an estimated premorbid modified Rankin Scale (mRS) score \>2; terminal illness; presence of serious medical comorbidities like end-stage renal failure and cardiac disease with severe hemodynamic compromise; infarction due to surgical complications or vasospasm; primary intracranial hemorrhage; coagulopathies; and high risk for surgery upon assessment by the medical team.

Primary outcomes:
measure: Functional status measured by modified Rankin Score (mRS)
timeFrame: up to six months
Secondary outcomes:
measure: Survival measured by modified Rankin Score (mRS)
timeFrame: up to six months
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines Manila
state: Metro Manila
Study officials:
affiliation: University of the Philippines Manila
name: Annabelle E Chua, MD
role: PRINCIPAL_INVESTIGATOR
References: