Intracerebral HemorrhagePOSTERNCT04707105
Prospective Cohort Study of Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 856 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 856 hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.
Who may be able to join
- Hospitalized patients over 18 years old of primary intracerebral hemorrhage.
Who cannot join
- patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.
- isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；
- surgical evacuation of hematoma；
- unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
- patients cannot be followed up for any reasons.
- patients death in 24 hours
- pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lusha Tong, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310000
Feng Gao, MD,PhD, 13588451471, 2202012@zju.edu.cn
About this study
Official title: A Prospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage
The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.
Read the detailed description
Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- primary intracerebral hemorrhage, hypertension, perihematomal edema, secondary brain injury, remote diffusion-weighted imaging lesions (R-DWILs), immune response, multimodel image, cohort, MRI
- Medical subject headings
- Cerebral Hemorrhage, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | a prospective cohort of patients of primary intracerebral hemorrhage in Second Affiliated Hospital, School of Medicine, Zhejiang University | |
| Second People's Hospital of Hangzhou City, Zhejiang Province | a prospective cohort of patients of primary intracerebral hemorrhage in Second People's Hospital of Hangzhou City, Zhejiang Province | |
| 4th Affiliated Hospital, School of Medicine at Zhejiang University | a prospective cohort of patients of primary intracerebral hemorrhage in 4th Affiliated Hospital, School of Medicine at Zhejiang University |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3
mRS 0-6, higher indicate worse outcome
Measured: 2-3years
Secondary outcomes (3)
Absolute peripheral hematoma edema(PHE) growth
absolute peripheral hematoma edema growth in CT/MRI measured by picture archiving and communication systems(PACS) system
Measured: 2-3years
Relative peripheral hematoma edema(rPHE)
rPHE：absolute PHE divided by hematoma volume in CT/MRI
Measured: 2-3years
National institute of health stroke scale（NIHSS score）
NIHSS 0-42, higher indicate worse outcome
Measured: 2-3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start29 Dec 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Gao, MD,PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707105
- Sponsor's protocol ID
- I2018001098
- Acronym
- POSTER
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04707105
- Acronym / sponsor ID
- POSTER / I2018001098
- Conditions
- Intracerebral Hemorrhage
- Keywords
- primary intracerebral hemorrhage, hypertension, perihematomal edema, secondary brain injury, remote diffusion-weighted imaging lesions (R-DWILs), immune response, multimodel image, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2021 (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 investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.
Detailed description
Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | – | –a prospective cohort of patients of primary intracerebral hemorrhage in Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Second People's Hospital of Hangzhou City, Zhejiang Province | – | –a prospective cohort of patients of primary intracerebral hemorrhage in Second People's Hospital of Hangzhou City, Zhejiang Province |
| 4th Affiliated Hospital, School of Medicine at Zhejiang University | – | –a prospective cohort of patients of primary intracerebral hemorrhage in 4th Affiliated Hospital, School of Medicine at Zhejiang University |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 856 hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.
Key inclusion criteria (1 listed)
- Hospitalized patients over 18 years old of primary intracerebral hemorrhage.
Key exclusion criteria (7 listed)
- patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.
- isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；
- surgical evacuation of hematoma；
- unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
- patients cannot be followed up for any reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3
Time frame: 2-3years
mRS 0-6, higher indicate worse outcome
3 secondary outcomes
Absolute peripheral hematoma edema(PHE) growth
Time frame: 2-3years
Relative peripheral hematoma edema(rPHE)
Time frame: 2-3years
National institute of health stroke scale（NIHSS score）
Time frame: 2-3years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Lusha Tong, MD,PhD contact
Feng Gao, MD,PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Intracerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Mar 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, MD,PhD (13588451471, 2202012@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3 (time frame: 2-3years). 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 18 Mar 2021.