Stereotactic Infarct Tissue Aspiration for Malignant Infarction of Middle Cerebral Artery

NCT02609256 | Terminated

• 1 other identifier: k(2015)32
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Middle Cerebral Artery Infarction

Keywords

Intracranial hypertension; cerebral herniation; Stereotactic infarct tissue aspiration; fatality; disability

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale(mRS) 0-3 vs mRS 4-6

  90±7days

Secondary Outcomes (4)

• National Institute of Health stroke scale(NIHSS)

  14±2days

• Mean survival time

  1 year

• death due to any reasons

  90±7days

• mRS 0-4 compared with mRS 5 or 6

  90±7days

Other Outcomes (5)

• The number of Local hemorrhage cases

  14±2 days

• The number of intracranial hemorrhage cases

  14±2 days

• Major cardiovascular events

  during the surgery

Study Arms (2)

Stereotactic infarct tissue aspiration

EXPERIMENTAL

Patients receive the stereotactic infarct tissue aspiration 24-48 hours after cerebral infarction beside medical therapy.

Procedure: Stereotactic infarct tissue aspiration; Other: Medical therapy

Medical therapy

SHAM COMPARATOR

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

Interventions

Stereotactic infarct tissue aspiration PROCEDURE

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.

Stereotactic infarct tissue aspiration

Medical therapy OTHER

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

Medical therapy; Stereotactic infarct tissue aspiration

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General hospital of shenyang military region

Shenyang, Liaoning, 110840, China

Location

Related Publications (8)

• 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.

  PMID: 26311142 BACKGROUND

• 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. doi: 10.1186/1745-6215-7-29.

  PMID: 16965617 BACKGROUND

• Neugebauer H, Heuschmann PU, Juttler 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.

  PMID: 23031451 BACKGROUND

• 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.

  PMID: 25101197 BACKGROUND

• 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. No abstract available.

  PMID: 24991475 BACKGROUND

• Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touze 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. doi: 10.1161/STROKEAHA.107.485235. Epub 2007 Aug 9.

  PMID: 17690311 BACKGROUND

• 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.

  PMID: 21190097 BACKGROUND

• Juttler E, Unterberg A, Woitzik J, Bosel 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.

  PMID: 24645942 BACKGROUND

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery; Intracranial Hypertension

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Huisheng Chen Jing Qiu, PhD

  Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Dept.

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CN (1)