Stroke, AcuteNCT06670456
Prospective Cohort of Patients With Intracerebral Hemorrhage
An observational study of Stroke, Acute and Intracerebral Hemorrhage, run by De-zhi Kang at 6 sites in China.
Trial summary
The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Intracerebral Hemorrhage
- How many people
- 3,000 participants
- Where
- 6 sitesChina
- Study dates
- 6 Nov 2023to 30 Dec 2028
- How long will I take part?
- 1 Year
- 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: Patients were diagnosed with spontaneous intracerebral hemorrhage and received no surgical intervention until enrollment; and those patients should have enough life expectancy and be assessable for the interview, according to their pre-stroke status.
Who may be able to join
- Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
- Underwent no surgical intervention;
Who cannot join
- Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
- Pre-stroke life expectancy \< 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure [NYHA: III-IV], severe chronic obstructive pulmonary disease [III-IV], chronic kidney disease requiring hemodialysis)
- Severe dependency or incorporation to interview (e.g., pre-stroke mRS\>3, severe dementia, intractable mental disease)
- Unsuitable for inclusion in the study in the opinion of the investigator
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Fu-xin Lin, MD, 86 13552358381, lfxstudy@126.com
Yan Zheng, 86 15659781312, zhengyan1997med@foxmail.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Wei-dong Liu, 86 15806976699
Han-yu Sun, 86 15910197887
- Recruiting
Anxi County Hospital
Quanzhou, Fujian
Jian-cai Chen, 86 13859736832
Nao-nan Weng, 86 13506910771
- Recruiting
Jinjiang Municipal Hospital
Quanzhou, Fujian
Xie-li Guo, 86 15960795588
Zhen Qi, 86 15880886519
- Recruiting
The Second Affiliated lospital of Xiamen Medical College
Xiamen, Fujian
Jian-wu Long, 86 13859934007
Chun Luo, 86 15960802895
- Recruiting
Zhangzhou Municipal Hospital
Zhangzhou, Fujian
Wei-wei Wang, 86 13806904186
Zhang Guo, 86 13605011127
About this study
Official title: Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage
The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.
- Conditions
- Stroke, Acute, Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Function
Assessed with modified Rankin Scale (0-6)
Measured: Discharge; 3, 6, 12 months after enrollment
Mortality
Measured: Discharge; 3, 6, 12 months after enrollment
Secondary outcomes (2)
Complications
Lately stoke, epilepsy, infections, cardiac event, ebolism.
Measured: Admission period; the 3, 6, 12 months after enrollment
Cognitive Status
Assessed with Telephone Interview for Cognitive Status - Modifed scale (0-51) Chinese version
Measured: The 3, 6, 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start6 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- De-zhi Kang
- Sponsor type
- University, hospital or other
- Collaborators
- Fuzhou University, Fujian Medical University, National Institute of Hospital Administration (China)
- Responsible party
- Sponsor-investigator, De-zhi Kang, First Affiliated Hospital of Fujian Medical University
- Investigators
- De-zhi Kang, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670456
- Sponsor's protocol ID
- 2022ZD01003
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified case data are available from the authors upon reasonable request, after request in writing to the corresponding authors and after approval by the study committee and principal investigators from each site.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06670456
- Acronym / sponsor ID
- 2022ZD01003
- Conditions
- Stroke, Acute, Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- De-zhi KangUniversity, hospital or other
- Collaborators
- Fuzhou University, Fujian Medical University, National Institute of Hospital Administration (China)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 1 Nov 2024 (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 designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with spontaneous intracerebral hemorrhage and received no surgical intervention until enrollment; and those patients should have enough life expectancy and be assessable for the interview, according to their pre-stroke status.
Key inclusion criteria (2 listed)
- Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
- Underwent no surgical intervention;
Key exclusion criteria (4 listed)
- Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
- Pre-stroke life expectancy \< 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure [NYHA: III-IV], severe chronic obstructive pulmonary disease [III-IV], chronic kidney disease requiring hemodialysis)
- Severe dependency or incorporation to interview (e.g., pre-stroke mRS\>3, severe dementia, intractable mental disease)
- Unsuitable for inclusion in the study in the opinion of the investigator
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
Neurological Function
Time frame: Discharge; 3, 6, 12 months after enrollment
Assessed with modified Rankin Scale (0-6)
Mortality
Time frame: Discharge; 3, 6, 12 months after enrollment
2 secondary outcomes
Complications
Time frame: Admission period; the 3, 6, 12 months after enrollment
Cognitive Status
Time frame: The 3, 6, 12 months after enrollment
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 1 Nov 2024.
- Individual participant dataSharing planned: Undecided. Deidentified case data are available from the authors upon reasonable request, after request in writing to the corresponding authors and after approval by the study committee and principal investigators from each site.
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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.
De-zhi Kang, MD principal investigator
First Affiliated Hospital of Fujian Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Intracerebral Hemorrhage, run by De-zhi Kang at 6 sites 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 2 inclusion and 4 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 De-zhi Kang, MD (86 15759413951, kdz99988@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Function (time frame: Discharge; 3, 6, 12 months after enrollment). The study lists 2 primary outcomes in all. 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 1 Nov 2024.