Stereotactic Infarct Tissue Aspiration for Malignant Infarction of Middle Cerebral Artery

Middle Cerebral Artery Infarction Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02609256
• Other study ID #: k(2015)32
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Infarction, Middle Cerebral Artery
• Middle Cerebral Artery Infarction

Intervention

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

Locations

Country	Name	City	State
China	General hospital of shenyang military region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (8)

Hatefi D, Hirshman B, Leys D, Lejeune JP, Marshall L, Carter BS, Kasper E, Chen CC. Hemicraniectomy in the management of malignant middle cerebral artery infarction: Lessons from randomized, controlled trials. Surg Neurol Int. 2014 May 15;5:72. doi: 10.4103/2152-7806.132589. eCollection 2014. — View Citation

Hofmeijer J, Amelink GJ, Algra A, van Gijn J, Macleod MR, Kappelle LJ, van der Worp HB; HAMLET investigators. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction. Trials. 2006 Sep 11;7:29. — View Citation

Jüttler E, Unterberg A, Woitzik J, Bösel J, Amiri H, Sakowitz OW, Gondan M, Schiller P, Limprecht R, Luntz S, Schneider H, Pinzer T, Hobohm C, Meixensberger J, Hacke W; DESTINY II Investigators. Hemicraniectomy in older patients with extensive middle-cerebral-artery stroke. N Engl J Med. 2014 Mar 20;370(12):1091-100. doi: 10.1056/NEJMoa1311367. — View Citation

Neugebauer H, Heuschmann PU, Jüttler E. DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols. BMC Neurol. 2012 Oct 2;12:115. doi: 10.1186/1471-2377-12-115. — View Citation

Raffiq MA, Haspani MS, Kandasamy R, Abdullah JM. Decompressive craniectomy for malignant middle cerebral artery infarction: Impact on mortality and functional outcome. Surg Neurol Int. 2014 Jun 26;5:102. doi: 10.4103/2152-7806.135342. eCollection 2014. — View Citation

Simard JM, Sahuquillo J, Sheth KN, Kahle KT, Walcott BP. Managing malignant cerebral infarction. Curr Treat Options Neurol. 2011 Apr;13(2):217-29. doi: 10.1007/s11940-010-0110-9. — View Citation

Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touzé E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser MG; DECIMAL Investigators. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke. 2007 Sep;38(9):2506-17. Epub 2007 Aug 9. — View Citation

van Middelaar T, Richard E, van der Worp HB, van den Munckhof P, Nieuwkerk PT, Visser MC, Stam J, Nederkoorn PJ. Quality of life after surgical decompression for a space-occupying middle cerebral artery infarct: A cohort study. BMC Neurol. 2015 Aug 28;15:156. doi: 10.1186/s12883-015-0407-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of Local hemorrhage cases		14±2 days
Other	The number of intracranial hemorrhage cases		14±2 days
Other	Major cardiovascular events		during the surgery
Other	The number of intracranial infection cases		14±2 days
Other	The number of Local infection cases		14±2 days
Primary	Modified Rankin Scale(mRS) 0-3 vs mRS 4-6		90±7days
Secondary	National Institute of Health stroke scale(NIHSS)	NIHSS score improvement	14±2days
Secondary	Mean survival time		1 year
Secondary	death due to any reasons		90±7days
Secondary	mRS 0-4 compared with mRS 5 or 6		90±7days