Molecular Mechanisms of Malignant Cerebral Edema After LHI

NCT03703284 | Unknown

• 1 other identifier: LHI
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Edema

Keywords

mechanism,; cerebral edema,; large hemispheric infarction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

LHI Hernia

Acute (\<=48h) large hemispheric infarction (LHI) patients who developed cerebral hernia in 5 days post-stroke

Other: Treatments to reduce intracranial pressure

LHI Non-Hernia

Acute (\<=48h) large hemispheric infarction (LHI) patients without cerebral hernia in 5 days post-stroke

Other: Treatments to reduce intracranial pressure

Healthy control

Healthy individuals

Interventions

Treatments to reduce intracranial pressure OTHER

Drugs such as mannitol, glycerin fructose, etc and/or surgery

LHI Hernia; LHI Non-Hernia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yan Zhang, M.D., PhD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhang, M.D., PhD

CONTACT

+86 13671376710; zhangylq@sina.com

Lili Cui, M.D., PhD

CONTACT

+86 13120301056; samantha47cmu@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: October 11, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)