Molecular Mechanisms of Malignant Cerebral Edema After LHI (LHI)

Molecular Mechanisms Underlying the Occurrence of Malignant Cerebral Edema After Large Hemispheric Infarction (LHI)

The study is to explore the molecular mechanisms underlying the occurrence of malignant cerebral edema (cerebral hernia) after large hemispheric infarction. Acute LHI (<=48h) patients that develop cerebral hernia or not within 5 days post-stroke onset, as well as the healthy controls will be studied. The participants will be followed for up to 6 months post stroke-onset, and their modified Rankin Scale (mRS) will be recorded. A mRS score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Edema
• Intervention / Treatment: Other: Treatments to reduce intracranial pressure

Detailed Description

A total of 80 patients with acute large hemispheric infarction (LHI) within 48h after occurrence admitted into NICU of Xuanwu Hospital as well as 40 healthy volunteers will be recruited. The patients' baseline characteristics, treatment and changes of clinical conditions will be recorded, and ICP monitoring (D2-D7 post-stroke), chest X-ray (D2, D7, D14 post-stroke), ECG (D2, D7, D14 post-stroke), cerebral vascular ultrasound, TCD and head MRI (T1WI, T2WI, FLAIR, DWI) on D2 and D14 post-stroke will be performed. Blood samples from both the LHI patients (D2, D4, D7, and D14 post-stroke) and the controls will be analyzed for NEU, TNF-alpha, IL-1b, IL-6, IL-8, IL-17, ICAM-1, VCAM-1, MPO, NE, MMP-9,miRNA, free dsDNA, H3CIT and NETosis levels. All patients were treated for brain edema with osmotic medications-either intravenous 20% mannitol or 10% hypertonic saline. In addition, some patients were treated with decompressive surgery.The patients will be followed up to 6 months and their modified Rankin Scale (mRS) will be recorded. A mRS score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one. Statistical differences in the different parameters between different groups at different time points will be analyzed by SPSS 22.0 software.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Yan Zhang, M.D., PhD; Phone Number: +86 13671376710; Email: zhangylq@sina.com
• Study Contact Backup: Name: Lili Cui, M.D., PhD; Phone Number: +86 13120301056; Email: samantha47cmu@gmail.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital of Capital Medical University
    • Contact: Lin-lin Fan, Phd; Phone Number: 8424 86-010-83198899; Email: windspring7139@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that are recruited into the Neuro-intensive care unit (NICU) of Xuanwu Hospital during 2018.1.1-2022.12.31

Description

Inclusion Criteria:

• 1. 18-80 years old;
• 2. Clinical diagnosis of large hemispheric infarction
• 3. Within 48h after stroke onset.

Exclusion Criteria:

• 1. Clinical diagnosis of severe infection;
• 2. Clinical diagnosis of severe heart, liver or kidney diseases;
• 3. Clinical diagnosis of bleeding tendency, active bleeding or hematological diseases;
• 4. Malignant tumor;
• 5. Modified Rankin Scale (mRS)<2 before stroke onset.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LHI Hernia; Acute (<=48h) large hemispheric infarction (LHI) patients who developed cerebral hernia in 5 days post-stroke	Other: Treatments to reduce intracranial pressure; Drugs such as mannitol, glycerin fructose, etc and/or surgery
LHI Non-Hernia; Acute (<=48h) large hemispheric infarction (LHI) patients without cerebral hernia in 5 days post-stroke	Other: Treatments to reduce intracranial pressure; Drugs such as mannitol, glycerin fructose, etc and/or surgery
Healthy control; Healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale	modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. A score of 0-4 is considered as a favorable outcome, whereas a score of 5-6 was considered as an unfavorable one. The reasons for death should be also recorded.	6 months after stroke onset

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Yan Zhang, M.D., PhD, Xuanwu Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: mechanism,; cerebral edema,; large hemispheric infarction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Edema; Brain Edema
• Other Study ID Numbers: LHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No