Strokectomy in Malignant Cerebral Media Infarction

NCT06489470 | Recruiting

• 1 other identifier: UMR1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Decompressive hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage, wherefore, strokectomy with resection of necrotic tissue has been proposed in some case series as an alternative surgical option. Thus, the aim of this study is to perform a pilot study by including patients with malignant MCA infarction and to check the feasibility of this specific surgical treatment.

Conditions

Stroke, Ischemic

Keywords

necrosectomy; alternative surgical treatment; strokectomy

Outcome Measures

Primary Outcomes (1)

• Rate of resurgery after necrosectomy of malignant MCA-infarction

  After the surgical treatment, the patients will be treated in the neurointensive care unit. During the clinical course, the necessity to perform a secondary surgery (e.g. hemicraniectomy) will be observed. For the safety of the patients, intracranial pressure monitoring will be continously performed as well.

  up to 2 weeks

Secondary Outcomes (2)

• Surgical complications

  up to 3 months

• Functional outcome via modified Rankin Scale (mRS; range 0-6; 0-3: favorable outcome, 4-6: unfavorable outcome) at 3 months

  up to 3 months

Study Arms (1)

Necrosectomy/Strokectomy

EXPERIMENTAL

Procedure: Strokectomy/Necrosectomy

Interventions

Strokectomy/Necrosectomy PROCEDURE

After obtaining CT-/MRT-perfusion, the infarcted area (e.g. infarct core) of malignant MCA-infarction is localized. By using the neuronavigation, surgical resection of necrotic tissue is performed in a non-eloquent area until the space occupying effect is released. At the end of the surgery, the bone flap is reinserted and fixated.

Necrosectomy/Strokectomy

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Ischemic middle cerebral artery (MCA) infarction at least two thirds of the MCA territory
• Clinical symptoms of acute unilateral MCA infarction less than 48 hours prior to the initiation of treatment

You may not qualify if:

• Preexisting modified Rankin Scale \>2
• Absence of pupillary reflexes or GCS \<6
• Intracerebral hemorrhage or other associated brain lesions
• Contraindications for surgery
• Estimated life expectancy of less than 3 years

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sae-Yeon Won, MD

  Neurosurgery, University Medical Center Rostock

  PRINCIPAL INVESTIGATOR

• Florian Gessler, MD PhD

  Neurosurgery, University Medical Center Rostock

  STUDY DIRECTOR

• Matthias Wittstock, MD

  Neurology, University Medical Center Rostock

  STUDY CHAIR

Central Study Contacts

Melanie Sparre

CONTACT

0381 494 6419; melanie.sparre@med.uni-rostock.de

Sae-Yeon Won, MD

CONTACT

0381 494 146067; sae-yeon.won@med.uni-rostock.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 8, 2024
• Study Start: June 15, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Up to 12 months

Locations

DE (1)