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Molecular Mechanisms of Malignant Cerebral Edema After LHI (LHI)

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ClinicalTrials.gov Identifier: NCT03703284
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Yan Zhang, Xuanwu Hospital, Beijing

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cerebral Edema 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 Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Molecular Mechanisms Underlying the Occurrence of Malignant Cerebral Edema After Large Hemispheric Infarction (LHI)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: 6 months after stroke onset ]
    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.


Biospecimen Retention:   Samples With DNA
Blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703284


Contacts
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Contact: Yan Zhang, M.D., PhD +86 13671376710 zhangylq@sina.com
Contact: Lili Cui, M.D., PhD +86 13120301056 samantha47cmu@gmail.com

Locations
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China
Xuanwu Hospital of Capital Medical University Recruiting
Beijing, China, 100053
Contact: Lin-lin Fan, Phd    86-010-83198899 ext 8424    windspring7139@163.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Yan Zhang, M.D., PhD Xuanwu Hospital of Capital Medical University
More Information
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Responsible Party: Yan Zhang, Associate Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03703284    
Other Study ID Numbers: LHI
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Zhang, Xuanwu Hospital, Beijing:
mechanism,
cerebral edema,
large hemispheric infarction
Additional relevant MeSH terms:
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Brain Edema
Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases