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

May 8, 2018 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • General Hospital of Shenyang Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
The number of Local hemorrhage cases
Time Frame: 14±2 days
14±2 days
The number of intracranial hemorrhage cases
Time Frame: 14±2 days
14±2 days
Major cardiovascular events
Time Frame: during the surgery
during the surgery
The number of intracranial infection cases
Time Frame: 14±2 days
14±2 days
The number of Local infection cases
Time Frame: 14±2 days
14±2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Investigators

  • Study Chair: Huisheng Chen Jing Qiu, PhD, Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • k(2015)32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Middle Cerebral Artery Infarction

Clinical Trials on Stereotactic infarct tissue aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe