Intracerebral HemorrhageNCT03085472
Chongqing Intracerebral Hemorrhage Study
An observational study of Intracerebral Hemorrhage and Stroke, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the senior consultant for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke, Hematoma
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2017to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 Years and older (Adult patients)
Who may be able to join
- Age >= 18 years
- Informed consent to participate in the study
- Patients diagnosed with CT-confirmed spontaneous Intracerebral Hemorrhage (ICH)
- Patients are willing to participate in the follow up assessment
Who cannot join
- Did not agree to participate in the study
- Secondary ICH to hemorrhagic infarction or tumor bleeding etc.
- Traumatic ICH
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Qi Li, MD;PhD, +(86) 18523381983, qili_md@126.com
Qi Li, MD,PhD
About this study
The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects, clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.
The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute intracerebral hemorrhage will be prospectively collected. The prognosis of patients with intracerebral hemorrhage will be assessed by using several outcome measure scales at different time points.
Read the detailed description
The Chongqing intracerebral hemorrhage study will try to address several key issues in ICH. The baseline clinical data including demographic, disease severity scores, prior drug history and relevant medical history, premorbid mRS scores will be prospectively recorded. The admission and follow-up imaging data of all registered patients will be saved as Dicom format for future use and review. The functional outcomes will be assessed and recorded by experienced neurologists.
- Conditions
- Intracerebral Hemorrhage, Stroke, Hematoma
- Keywords
- intracerebral hemrrohage, stroke, China, hematoma, CT, predictor, prognosis, outcome
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hematoma
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 |
|---|---|---|
| benigh hematoma | Patients with novel imaging markers or clinical features suggestive of a relatively benigh hematoma (less likely to expand and have a relatively good outcome). | |
| malignant hematoma | Patients with novel imaging markers or clinical features suggestive of a relatively bad hematoma (more likely to expand and have a relatively poor outcome). |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma volume growth at 24 hours
To assess early hematoma volume growth at 24 hours
Measured: 24 hours
Secondary outcomes (8)
functional outcome at 3 months assessed by modified Ranking Scale
assess functional outcome at 3months using mRS
Measured: 3 months
early neurological deterioration assessed by NIHSS score at 24 hours
To assess early neurological deterioration using NIHSS score at 24 hours
Measured: 24 hours
early neurological deterioration assessed by NIHSS at 48 hours
To assess early neurological deterioration using NIHSS score at 48 hours
Measured: 48 hours
early neurological deterioration assessed by NIHSS score
To assess early neurological deterioration using NIHSS score at 72 hours
Measured: 72hours
perihematoma edema volume measurement at 24 hours
to measure the perihematoma edema volume at 24 hours
Measured: 24 hours
perihematoma edema volume measurement at 72 hours
to measure the perihematoma edema volume at 72 hours
Measured: 72 hours
intraventricular hemorrhage growth
to assess the presence of IVH at 24 hours
Measured: 24 hours
major thromboembolic events
to assess the thromboembolic events 2 weeks after admission
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start16 Feb 2017
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Jan 2023 (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 First Affiliated Hospital of Chongqing Medical UniversityThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Li, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085472
- Sponsor's protocol ID
- X1517
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chongqing Intracerebral Hemorrhage Study
- ClinicalTrials.gov ID
- NCT03085472
- Acronym / sponsor ID
- X1517
- Conditions
- Intracerebral Hemorrhage, Stroke, Hematoma
- Keywords
- intracerebral hemrrohage, stroke, China, hematoma, CT, predictor, prognosis, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Mar 2017 (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 Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects, clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.
The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute intracerebral hemorrhage will be prospectively collected. The prognosis of patients with intracerebral hemorrhage will be assessed by using several outcome measure scales at different time points.
Detailed description
The Chongqing intracerebral hemorrhage study will try to address several key issues in ICH. The baseline clinical data including demographic, disease severity scores, prior drug history and relevant medical history, premorbid mRS scores will be prospectively recorded. The admission and follow-up imaging data of all registered patients will be saved as Dicom format for future use and review. The functional outcomes will be assessed and recorded by experienced neurologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benigh hematoma | – | –Patients with novel imaging markers or clinical features suggestive of a relatively benigh hematoma (less likely to expand and have a relatively good outcome). |
| malignant hematoma | – | –Patients with novel imaging markers or clinical features suggestive of a relatively bad hematoma (more likely to expand and have a relatively poor outcome). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 Years and older (Adult patients)
Key inclusion criteria (4 listed)
- Age >= 18 years
- Informed consent to participate in the study
- Patients diagnosed with CT-confirmed spontaneous Intracerebral Hemorrhage (ICH)
- Patients are willing to participate in the follow up assessment
Key exclusion criteria (3 listed)
- Did not agree to participate in the study
- Secondary ICH to hemorrhagic infarction or tumor bleeding etc.
- Traumatic ICH
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
hematoma volume growth at 24 hours
Time frame: 24 hours
To assess early hematoma volume growth at 24 hours
8 secondary outcomes
functional outcome at 3 months assessed by modified Ranking Scale
Time frame: 3 months
early neurological deterioration assessed by NIHSS score at 24 hours
Time frame: 24 hours
early neurological deterioration assessed by NIHSS at 48 hours
Time frame: 48 hours
early neurological deterioration assessed by NIHSS score
Time frame: 72hours
perihematoma edema volume measurement at 24 hours
Time frame: 24 hours
perihematoma edema volume measurement at 72 hours
Time frame: 72 hours
intraventricular hemorrhage growth
Time frame: 24 hours
major thromboembolic events
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- 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. This study is not recruiting at the moment.
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 and Stroke, run by First Affiliated Hospital of Chongqing Medical University 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 4 inclusion and 3 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 21 Mar 2017. 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 Qi Li, MD;PhD (86 18523381983, qili_md@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematoma volume growth at 24 hours (time frame: 24 hours). 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 21 Mar 2017.