Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI)

University of the Philippines

Status: Terminated

Conditions: Infarction

Treatments: Procedure: Hemicraniotomy; Procedure: Standard medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02002234

RIDO 2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Medical Treatment Arm

Other group

Description:

Received standardized medical therapy in an intensive care unit (ICU), which included elevation of the head of bed at 30°, intermittent hyperventilation administered, and intravenous mannitol. Mean arterial pressure was maintained above 90 mm Hg. Hemoglobin concentration was maintained at all times above 90 g/L. Hyperglycemia, hyperthermia and hypotension were avoided or corrected when present.

Treatment:

Procedure: Standard medical treatment

Surgery with Medical Treatment Arm

Other group

Description:

Aside from receiving standardized medical therapy, decompressive hemicraniectomy was performed by removing a large bone flap at least 12 cm in diameter and included parts of the frontal, temporal, parietal and occipital bones, with further craniectomy to the floor of the temporal fossa. The dura was opened widely and duraplasty was performed using periosteum and temporalis fascia. The bone flap was either stored in a subcutaneous pocket in the abdomen or placed in the bone bank. Cranioplasty was performed during a separate admission on an elective basis not earlier than 6 months from the initial surgery.

Treatment:

Procedure: Hemicraniotomy