Cerebral EdemaLHINCT03703284
Molecular Mechanisms of Malignant Cerebral Edema After LHI
An observational study of Cerebral Edema, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Edema
- What is being tested?
- Treatments to reduce intracranial pressure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that are recruited into the Neuro-intensive care unit (NICU) of Xuanwu Hospital during 2018.1.1-2022.12.31
Who may be able to join
- 1. 18-80 years old;
- 2. Clinical diagnosis of large hemispheric infarction
- 3. Within 48h after stroke onset.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, 100053
Lin-lin Fan, Phd, 86-010-83198899 ext. 8424, windspring7139@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Edema
- Being tested
- Treatments to reduce intracranial pressure
- Keywords
- mechanism,, cerebral edema,, large hemispheric infarction
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatments to reduce intracranial pressureOther
Drugs such as mannitol, glycerin fructose, etc and/or surgery
| Study group | Role | What they receive |
|---|---|---|
| LHI Hernia | Acute (<=48h) large hemispheric infarction (LHI) patients who developed cerebral hernia in 5 days post-stroke Receives: Other: Treatments to reduce intracranial pressure | |
| LHI Non-Hernia | Acute (<=48h) large hemispheric infarction (LHI) patients without cerebral hernia in 5 days post-stroke Receives: Other: Treatments to reduce intracranial pressure | |
| Healthy control | Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral EdemaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhang, Xuanwu Hospital, Beijing
- Investigators
- Yan Zhang, M.D., PhD, Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703284
- Sponsor's protocol ID
- LHI
- Acronym
- LHI
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Underlying the Occurrence of Malignant Cerebral Edema After Large Hemispheric Infarction (LHI)
- ClinicalTrials.gov ID
- NCT03703284
- Acronym / sponsor ID
- LHI / LHI
- Conditions
- Cerebral Edema
- Keywords
- mechanism,, cerebral edema,, large hemispheric infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LHI Hernia | – | Other: Treatments to reduce intracranial pressureAcute (<=48h) large hemispheric infarction (LHI) patients who developed cerebral hernia in 5 days post-stroke |
| LHI Non-Hernia | – | Other: Treatments to reduce intracranial pressureAcute (<=48h) large hemispheric infarction (LHI) patients without cerebral hernia in 5 days post-stroke |
| Healthy control | – | –Healthy individuals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are recruited into the Neuro-intensive care unit (NICU) of Xuanwu Hospital during 2018.1.1-2022.12.31
Key inclusion criteria (3 listed)
- 1. 18-80 years old;
- 2. Clinical diagnosis of large hemispheric infarction
- 3. Within 48h after stroke onset.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatments to reduce intracranial pressureDrugs such as mannitol, glycerin fructose, etc and/or surgery | Other | LHI Hernia, LHI Non-Hernia |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhang, M.D., PhD principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Edema, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, M.D., PhD (+86 13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 6 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.