Molecular Mechanisms of Malignant Cerebral Edema After LHI

Cerebral Edema Clinical Trial

— LHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03703284
• Other study ID #: LHI
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: June 2023

Study information

• Verified date: March 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Yan Zhang, M.D., PhD
• Phone: +86 13671376710
• Email: zhangylq[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Edema
• Cerebral Edema
• Edema

Intervention

Other:
• Treatments to reduce intracranial pressure
Drugs such as mannitol, glycerin fructose, etc and/or surgery

Locations

Country	Name	City	State
China	Xuanwu Hospital of Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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