DECOMPRESSIVE SURGERY FOR THE TREATMENT OF MALIGNANT INFARCTION OF THE MIDDLE CEREBRAL ARTERY: A RANDOMIZED, CONTROLLED TRIAL IN A TURKISH POPULATION "DEMITUR TRIAL"

Completed

Phase N/A Results

Trial Description

Is the surgery than intensive medical treatment in patients with malignant infarction of the middle cerebral artery.

Interventions

  • Hemicraniectomy Procedure
    Other Names: hemicraniectomy
    Intervention Desc: Surgical procedure to reduce intracranial pressure after large hemispheric infaction.
  • Standard Medical Care Procedure
    Intervention Desc: per the National Guidelines for Stroke.

Trial Design

Randomised, open treatment trial.

Patient Involvement

Patients will be randomized to either surgery or standard medical treatment. Patients had functional outcome, as measured by mRS score, at 6 and 12 months. Also Barthel Index ?85 at 6 and 12 months, the National Institutes of Stroke Scale, and quality of life assessed by the Turkish version of the Stroke Impact Scale 2.0 (SIS) at 6 and 12 months.Decompressive surgery was performed with a large hemicraniectomy ipsilateral to the stroke, a bone flap as large as possible including temporal, frontal, parietal, and some occipital squama.

Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome measure was the modified Rankin scale (mRS) score at 1 year, which was dichotomised between good (0–3) and poor (4–6) outcome.
Secondary Secondary outcome measures were Barthel Index ?85 at 6 and 12 months, the National Institutes of Stroke Scale, and quality of life assessed by the Turkish version of the Stroke Impact Scale 2.0 (SIS)at 6 and 12 months.

Sponsors

Ege University, Izmir