HeMMI
Hemicraniectomy For Malignant Middle Cerebral Artery Infarcts
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Status:
Ongoing. Currently recruiting patients. As of March, 2008 28 patients have been randomized. Fifteeen patients have been randomized to the surgical arm.
Purpose:
To determine whether hemicraniectomy will improve outcome in patients with malignant middle cerebral artery infarction compared to medical treatment alone.
Interventions:
Hemicraniectomy
Surgical procedure to reduce intracranial pressure after large hemispheric infaction.
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Year Started:
2004
Design:
Open randomized clinical trial.
Inclusion Criteria
Patients diagnosed clinically and radiographically with ischemic stroke in the middle cerebral artery territory;GCS 6-14 (R MCA) or 5-9 (L MCA) or score of >1 on the 'level of consciousness" category of NIHSS, with imaging done to rule out bleed or stroke mimickers.
Exclusion Criteria
Patients with a previos disabling neurological disease or a modified Rankin score > 2, Glasgow Coma Scale score of < 5, terminal illness, infarction due to surgical complications or vasopasm, primary intracranial hemorrhage or coagulopathies.
Patient Involvement:
Patients medically cleared for possible surgery will be randomized to receive either standard medical treatment or hemicraniectomy with duraplasty. The GCS score and NIHSS score will be monitored daily for the first 7 days, at 2 weeks, at discharge, 1, 3, and 6 months. The modified Rankin score and Barthel Index will be assessed at discharge, 2 weeks, 1, 3, and 6 months.
Primary Outcome:
GCS, NIHSS, modified Rankin score and Barthel Index; Functional outcome at 6 months (Rankin <4 or Barthel Index >60).
Results:
Have been unable to get updated results as of 2/15/08 when placed online-jh.
Source of Information:
Presented at the 29th International Stroke Conference [February 2004].
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Web Links and Publications:
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This information last updated on: 3/17/2008
Reviewed on: 06/16/2009.
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