Clinical Trial: Stereotactic Infarct Tissue Aspiration for Malignant Infarction of Middle Cerebral Artery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Stereotactic Infarct Tissue Aspiration (SITA) for Malignant Infarction of Middle Cerebral Artery

Brief Summary: Malignant middle cerebral artery infarction(MMCI) has a high rate of disability and mortality. At present, there is no effective treatment except for craniotomy decompression, but the controversy of the craniotomy decompression still exists. The project is a prospective, randomized, single center, open label, clinical controlled trail. The eligible patients for enrollment are as follows: (1) malignant cerebral artery infarction within 48h onset; (2) craniotomy decompression can not be performed due to the contraindications, or refused by the patient or relatives. The patients are randomly assigned into 2 groups: (1)Medical therapy group: receiving osmotic therapy with mannitol and glycerol fructose，anti-platelet treatment, statins, and other symptomatic treatments such as controlling blood pressure, blood sugar, and infection, tracheal intubation or incision, etc; (2) Stereotactic infarct tissue aspiration (SITA) group: on the basis of medical treatment, receiving minimally invasive aspiration of infarct tissue 24-48 hours after stroke attacked. This study is aimed at comparing the efficacy and safety of of SITA in patients with MMCI.

Detailed Summary:

Malignant middle cerebral artery infarction (MMCI) has a fatality rate of up to 80%, due to massive brain edema, increased intracranial pressure, and cerebral herniation. The herniation-induced death usually occured during the first week, despite aggressive osmotherapy with mannitol or hypertonic saline, sedation, and eventually hyperventilation, buffers, or hypothermia. A growing evidence show that decompression craniectomy (DC) can produce a significant reduction in mortality rate and an improvement in neurological outcome, but the controversy of the DC still exists. There is an urgent need to find a more effective treatment method. Given that brain tissue necrosis-induced edema and cerebral herniation is the key reason of fatality and disability of MMCI patients, the investigators argue that the reduction of cerebral tissue volume by stereotactic infarct tissue aspiration (SITA) is likely to reach the decompression effect similar to the DC. Recently, the investigators performed SITA in 2 MMCI patients who were qualified for decompressive craniectomy, but refused by patient relatives, and their neurological function significantly improved.

The project is a prospective, randomized, single center, open label, clinical controlled trail. The eligible patients for enrollment are as follows: (1)ages from 40 to 90 years old; (2) malignant cerebral artery infarction within 48h onset; (3) craniotomy decompression can not be performed due to the contraindications, or refused by the patient or relatives. The patients are randomly assigned into 2 groups: (1) Medical therapy group: receiving osmotic therapy with mannitol and glycerol fructose，anti-platelet treatment, statins, and other symptomatic treatments such as controlling blood pressure, blood sugar, and infection, and tracheal intubation or incision, etc; (2) SITA group: receiving minimally invasive aspiration of infar
Sponsor: General Hospital of Shenyang Military Region

Current Primary Outcome: Modified Rankin Scale(mRS) 0-3 vs mRS 4-6 [ Time Frame: 90±7days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • National Institute of Health stroke scale(NIHSS) [ Time Frame: 14±2days ]
    NIHSS score improvement
  • Mean survival time [ Time Frame: 1 year ]
  • death due to any reasons [ Time Frame: 90±7days ]
  • mRS 0-4 compared with mRS 5 or 6 [ Time Frame: 90±7days ]


Original Secondary Outcome: Same as current

Information By: General Hospital of Shenyang Military Region

Dates:
Date Received: November 11, 2015
Date Started: December 2015
Date Completion: December 2017
Last Updated: July 29, 2016
Last Verified: July 2016