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Stereotactic Infarct Tissue Aspiration for Malignant Infarction of Middle Cerebral Artery (SMART)

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ClinicalTrials.gov Identifier: NCT02609256
Recruitment Status : Terminated
First Posted : November 20, 2015
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

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.

Condition or disease Intervention/treatment Phase
Middle Cerebral Artery Infarction Procedure: Stereotactic infarct tissue aspiration Other: Medical therapy Not Applicable

Detailed Description:

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 infarct tissue 24-48 hours after stroke attacked on the basis of medical treatment. This study is aimed at comparing the efficacy and safety of of SITA in patients with MMCI.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Infarct Tissue Aspiration (SITA) for Malignant Infarction of Middle Cerebral Artery
Study Start Date : December 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Stereotactic infarct tissue aspiration
Patients receive the stereotactic infarct tissue aspiration 24-48 hours after cerebral infarction beside medical therapy.
Procedure: Stereotactic infarct tissue aspiration
The patient posed supine position to expose local skin and puncture point was located at 6.5 cm behind the hairline of the lesion side, and 5.0 cm lateral of midline. After routine skin preparation and disinfection, 5% lidocaine 2-5 ml was injected for local anesthesia. The skin was cut to expose periosteum by a scalpel. After skull was vertically drilled through with a 6mm diameter hole, a sterile tube with a needle in tube was put about 8 cm into centrum semiovale. The needle was put out and about 50ml necrosis brain tissue was aspirated by a 20 ml syringe. The tube was fixed into the skin about 2 cm after subcutaneous tunnel, and connected to the drainage bag. Surgical area was sterilized and wrapped by sterile gauze bandage.

Other: Medical therapy
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

Sham Comparator: Medical therapy
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;
Other: Medical therapy
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




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

Secondary Outcome Measures :
  1. National Institute of Health stroke scale(NIHSS) [ Time Frame: 14±2days ]
    NIHSS score improvement

  2. Mean survival time [ Time Frame: 1 year ]
  3. death due to any reasons [ Time Frame: 90±7days ]
  4. mRS 0-4 compared with mRS 5 or 6 [ Time Frame: 90±7days ]

Other Outcome Measures:
  1. The number of Local hemorrhage cases [ Time Frame: 14±2 days ]
  2. The number of intracranial hemorrhage cases [ Time Frame: 14±2 days ]
  3. Major cardiovascular events [ Time Frame: during the surgery ]
  4. The number of intracranial infection cases [ Time Frame: 14±2 days ]
  5. The number of Local infection cases [ Time Frame: 14±2 days ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ages from 40 to 90
  2. within 48 hours of onset
  3. brain imaging confirmed malignant middle cerebral artery infarction (DWI+MRA)
  4. infarction volume > 145ml
  5. craniotomy decompression can not be performed due to the contraindications, or refused by the patient or relatives
  6. signed informed consent.

Exclusion Criteria:

  1. hemorrhagic stroke
  2. severe infection or severe disfunction of liver, kidney, hematopoietic system, endocrine system and other serious diseases
  3. other clinical trials within 3 months
  4. a negative attitude towards SITA by patient or relatives
  5. other conditions not eligible for the trail judged by the researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609256


Locations
China, Liaoning
General hospital of shenyang military region
Shenyang, Liaoning, China, 110840
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Study Chair: Huisheng Chen Jing Qiu, PhD Director

Publications:

Responsible Party: Hui-Sheng Chen, Director of Neurology Dept., General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02609256     History of Changes
Other Study ID Numbers: k(2015)32
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:
Intracranial hypertension
cerebral herniation
Stereotactic infarct tissue aspiration
fatality
disability

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases