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Molecular Mechanisms of Malignant Cerebral Edema After LHI

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03703284
Acronym
LHI
Enrollment
120
Registered
2018-10-11
Start date
2018-01-01
Completion date
2023-06-30
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Edema

Keywords

mechanism,, cerebral edema,, large hemispheric infarction

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.

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.

Interventions

OTHERTreatments to reduce intracranial pressure

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

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
modified Rankin Scale6 months after stroke onsetmodified 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.

Countries

China

Contacts

Primary ContactYan Zhang, M.D., PhD
zhangylq@sina.com+86 13671376710
Backup ContactLili Cui, M.D., PhD
samantha47cmu@gmail.com+86 13120301056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026